National Framework

A ROADMAP FOR RESEARCH
FIRST EDITION – DECEMBER 2009

Canadian Institutes of Health Research
Health Canada
Public Health Agency of Canada
© Canadian Breast Cancer Research Alliance, 2009 Contact:

Published December 2009 nationalframework@cbcra.ca
ISBN 978-0-9864969-0-5 416-596-6598
This document is available at www.nationalframework.ca
TABLE OF CONTENTS
Foreword from Co-Chairs 5
Listing of Working Groups 5

Part One: National Summit Working Group Members 5
Part Two: National Framework Working Group Members 6
1. Executive Summary 7
2. Summary 9
Research Themes 11
Research Priorities 12
3. Rationale for the National Framework 17

Setting the Stage 17
Defining the National Framework 17
Stakeholder Expectations 18
Outline of this Document 18
4. Setting the Context 19

Overview 19
Impact on Canadians 19
Funding of Breast Cancer Research 20
Strengths and Limitations of the Current Breast Cancer Research System 22
5. Approach and Methodology 23

Overview 23
Methodology 24
Part One: Preparation for the National Summit 24
Part Two: Establishing Priorities Following the National Summit 31
6. Identifying the Research Priorities 33

Overview 33
Foundational Elements of the Breast Cancer Research System in Canada 33
Research Priorities by CSO Category 33
CSO Category 1: Biology 34
CSO Category 2: Etiology (Causes of cancer) 38
CSO Category 3: Prevention 42
CSO Category 4: Early Detection, Diagnosis and Prognosis 43
CSO Category 5: Treatment 47
CSO Category 6: Cancer Control, Survivorship, and Outcomes Research 51
CSO Category 7: Scientific Model Systems 56
Prioritized Research Themes 58
A. Mechanisms of Cancer Development 58
B. Molecular Detection and Prediction 58
C. Personalized Medicine 59
D. Cancer Progression and Dissemination 60
E. Psychosocial, Survivorship and Health Services 60
F. Transferring Knowledge into Practice 61
Research System/Infrastructure Supports 61
Discussion 62
continued...
1.
2.
7. Call to Action 65
Overview 65
Collaborating for Success 65
CBCRA’s Commitment 66
Turning Strategy into Action 66

Appendices 69
Appendix A – CBCRA Board of Directors (2007-2009) 69
Appendix B – Detailed Breakdown of Funding by CSO Code 71
Appendix C – Definition of Key Terms 75

Figures and Tables
Figure 1: Cancer Research Investment by Cancer Site 20
Figure 2: Breast Cancer Investment by CSO Category 21
Figure 3: Breast Cancer Research Investment by Funding Mechanism and CSO Category 22
Figure 4: Process Overview – Developing the National Framework 23
Table 1: Summary Statistics for Breast Cancer in Females, Canada - 2009 (estimates) 19
Table 2: Summary of Data Gathered from Key Stakeholders Prior to the National Summit 25
Table 3: List of “State of the Science” Papers – May 2008 26
Table 4: Summary of Consolidated Findings from Stakeholder Input – Prior to the National Summit, May 2008 27
Table 5: Distribution of 2007 Breast Cancer Research Investment by CSO Code 70
3.
4.
FOREWORD FROM CO-CHAIRS
Canada is at the forefront of international efforts across many areas of breast cancer research. Our expertise and
technical capabilities are highlighted by an ever-increasing number of significant discoveries by Canadian cancer
researchers.
From a strategic standpoint, it became clear to many of us in the breast cancer community that to take full advantage
of this country’s outstanding research talent and capabilities, a more co-ordinated national approach to breast cancer
research is required. Without the guidance of a high-level plan there is a risk that research will occur in silos and that
resources will not be used for maximum effectiveness.
The National Breast Cancer Research Framework – the first initiative of its kind for breast cancer research in the world –
provides such an approach.
The National Framework presented here is the product of a broad-based, comprehensive and collaborative process.
It reflects the input of funders, breast cancer survivors, researchers and clinicians from across the country and, looking
ahead, offers a coherent vision of the most promising areas for breast cancer research. We encourage stakeholders to
become familiar with the research priorities identified within the National Framework, and funders to collaborate on
funding decisions based on those priorities.
As co-chairs and active researchers, we have full confidence in the process used for developing the National Framework.
We are also enthusiastic about the direction it sets for breast cancer research in this country and have high expectations
for the positive outcomes resulting from more focused research activity.
We urge Canada’s breast cancer research community to fully support the National Framework and its recommendations.
By harnessing our strengths and working more effectively together, we can maximize the benefits of Canadian breast
cancer research.
Eva Grunfeld MSc, MD, DPhil, CCFP Morag Park PhD, FRSC
Co-Chair, National Framework Working Group Co-Chair, National Framework Working Group
Director, Knowledge Translation Research Scientific Director
Health Services Research Program CIHR Institute of Cancer Research
Cancer Care Ontario Member, CBCRA Board of Directors
and the Ontario Institute for Cancer Research Montreal, Quebec
Toronto, Ontario
LISTING OF WORKING GROUPS

The contribution of the following individuals to the development of this report is acknowledged with gratitude:
Part One: National Summit Working Group Members

Dr. Phil Branton (Co-Chair), CIHR Dr. Ivo Olivotto, CBCRA Research Advisory
Dr. Moira Stilwell (Co-Chair), CBCF Committee Chair
Dr. Elizabeth Eisenhauer, NCIC/CCS Dr. Morag Park, Researcher
Diana Ermel, CBCN Dr. Cathy Popadiuk, CBCRA Board Member-at-Large
Heidi Liepold, PHAC
5.
Part Two: National Framework Working Group Members
Dr. Eva Grunfeld (Co-Chair) Dr. Thomas Hack
Director, Knowledge Translation Research Associate Professor, Faculties of Medicine, Nursing, and
Health Services Research Program Graduate Studies, University of Manitoba
Cancer Care Ontario and the Ontario Institute for Clinical Psychologist, CancerCare Manitoba
Cancer Research Member, CBCRA Research Advisory Committee
Health services, survivorship Psychosocial interventions for cancer patients
Dr. Morag Park (Co-Chair) Dr. Claire Holloway

Scientific Director, CIHR Institute of Cancer Research Associate Scientist and Surgical Oncologist
Member, CBCRA Board of Directors Sunnybrook Health Sciences Centre
Molecular biology of cancer Chair, CBCRA Research Advisory Committee
Clinician/Surgeon, Image-guided surgery, Translational
Dr. Heather Bryant research, Population based studies
Vice-President, Cancer Control, Canadian Partnership
Against Cancer Dr. Tom Hudson
Cancer epidemiology and prevention President and Scientific Director
Ontario Institute for Cancer Research
Dr. Mario Chevrette Cancer genetics and genomics
President, The Cancer Research Society
Molecular biology of cancer Dr. Victor Ling
Scientific Director, Terry Fox Research Institute
Dr. Elizabeth Eisenhauer Cancer biology
Co-Chair, Canadian Cancer Research Alliance
Chair, Canadian Partnership Against Cancer Research Dr. Sylvie Mader
Action Group Professor, Institute for Research in Immunology and
Member, CBCRA Board of Directors Cancer, University of Montreal
Clinical trials Member, CBCRA Research Advisory Committee
Endocrinology, cellular and molecular biology of cancer
Dr. Margaret Fitch
Head, Oncology Nursing, Sunnybrook Research Institute Dr. Michael Pollak
Oncology nursing and supportive care Director, Cancer Prevention Centre, Segal Cancer Centre
Professor, Department of Oncology, McGill University
Dr. Christine Friedenreich Cancer therapy and cancer prevention strategies
Research Scientist, Division of Population
Health and Information Dr. Jim Woodgett
Tom Baker Cancer Centre Director of Research, Samuel Lunenfeld Research Institute
Cancer etiology and prevention Mount Sinai Hospital
Member, CBCRA Research Advisory Committee
Dr. Karen Gelmon Molecular biology of cancer
Head Investigational Drug Program, Advanced Therapeutics
Dr. Martin Yaffe
Dept. of Medical Oncology, BC Cancer Agency
Senior Scientist, Sunnybrook Health Sciences Centre
Clinical trials, drug development
Member, CBCRA Research Advisory Committee
Early detection, digital mammography
Staff Support
Nicola Lewis, CBCRA Executive Director
Dr. Pascale Macgregor, CBCRA Research Program Director
Dr. Jane Cooke-Lauder, Bataleur Enterprises Inc. (consultant)
6. Chapter 1: Executive Summary

1. EXECUTIVE SUMMARY
Breast cancer is the most frequently diagnosed type of cancer among Canadian women. Over the last two decades,
it has received an increasing amount of attention leading to vast improvements in screening and treatment. However,
female breast cancer rates in Canada remain among the highest in the world1 leading to a consensus view that more
research is required to successfully prevent and manage this complex disease.
Investment in breast cancer research has supported the development of considerable Canadian research talent and
capabilities and has fostered many breakthrough discoveries. However, to maximize Canada’s contribution to breast
cancer research, now and in the future, there is a need for more effective use of resources, increased collaboration and
agreement on a set of national research priorities.
To address this need, the Canadian Breast Cancer Research Alliance (CBCRA) established a broad-based consultation
process to develop a strategic framework for the funding of breast cancer research in Canada.
The resulting National Framework for Breast Cancer Research (National Framework) is a Roadmap for Research. It
identifies existing and emerging research priorities, encourages collaboration among funders and articulates a call to
action aimed at all members of the Canadian breast cancer community.
The National Framework represents a new paradigm

in research prioritization
Although national plans currently exist for cancer, diabetes, and heart disease, the National Framework is unique in its
focus on research and its call for collaboration among funders. Most significantly, this National Framework:
1. Defines strategic research priorities, covers all aspects of the breast cancer research system and includes areas
that could be relevant to other cancer sites;
2. Establishes a streamlined approach for achieving and measuring high levels of scientific rigour and research
impact;
3. Is forward looking and acknowledges the importance of both short-term and longer-term initiatives.
The National Framework identifies areas for high-impact research

Research priorities were selected through a rigorous, consultative process to ensure agreement that each of these
research advances would benefit Canadians and improve Canada’s global competitiveness in cancer research. Suggested
areas for investment are presented in two linked ways: as broader overarching themes and as more focused individual
research priorities.
Six overarching research themes were identified:
A. Mechanisms of Cancer Development
B. Molecular Detection and Prediction
C. Personalized Medicine
D. Cancer Progression and Dissemination
E. Psychosocial, Survivorship and Health Services
F. Transferring Knowledge into Practice.
1
Canadian Cancer Society’s Steering Committee: Canadian Cancer Statistics 2009. Toronto: Canadian Cancer Society, 2009.
www.cancer.ca/statistics.
Chapter 1: Executive Summary 7.

In addition, 17 high-impact research priorities were identified, mapping to the Common Scientific Outline, an organizing
framework used by most national and international research granting agencies:
CSO Category Research Priority
1. GENETICS – The genetic and epigenetic basis of breast cancer development

2. INITIATION – Deciphering the molecular pathways implicated in breast cancer initiation
Biology
3. METASTASIS – Understanding the cause of metastatic breast cancer and identifying new
avenues for interventions
4. BREAST CANCER RISK – The influence of lifestyle and environmental factors on the risk of
developing breast cancer
Etiology 5. BREAST CANCER CAUSES I – The genetics and hormonal causes of breast cancer
6. BREAST CANCER CAUSES II – Understanding the interplay of multicausal factors: genetics
and environment
7. PREVENTION (INTERVENTIONS) – Interventions to study the influence of lifestyle and
Prevention
environmental factors on the risk of developing breast cancer
8. DETECTION – Better approaches to early detection and diagnosis

Early Detection,
Diagnosis and 9. BIOMARKERS I – Development and evaluation of new biomarkers (including biomarkers for
Prognosis diagnosis) and the optimization of treatments for individual patients
10. BIOMARKERS II – Clinical setting/clinical trials to assess clinical sensitivity and specificity of
new biomarkers
11. NEW TREATMENTS – Discovery and development of new treatments for breast cancer
Treatment
12. CLINICAL TRIALS – Clinical trials of new promising therapies
13. SURVIVORSHIP AND QUALITY OF LIFE INTERVENTIONS – Psychosocial and survivorship

interventions
Cancer Control, 14. HEALTH-CARE ISSUES – Analysis of the financial and health-care delivery issues facing breast
Survivorship, cancer patients across the cancer continuum
and Outcomes 15. KNOWLEDGE TRANSLATION AND BEST PRACTICES – Interventions to improve knowledge
Research translation and disseminate best practices in breast cancer across the cancer continuum
16. LINK WITH CLINICAL DATA – Developing mechanisms to link clinical trial data with
administrative health databases for studies on long-term outcomes and late effects
Scientific Model 17. ANIMAL MODELS – Developing new animal and cellular models to study response to
Systems therapeutics and mimic human breast cancer development
The National Framework requires a realignment of existing and

some new funding
In 2007, at least $46.8M was spent on breast cancer research in Canada, most of the investment being made in the form
of investigator-initiated operating grants, also known as discovery research. Although this type of funding mechanism has
historically received the major share of research funding, there appears to be a general trend toward increased support
for more targeted research.
In assessing the funding needs for the National Framework’s 17 research priorities, a continuation of balanced support
8. Chapter 1: Executive Summary

for ongoing research initiatives is endorsed. However, new thinking about research investment is also encouraged, given
that a third of the identified research priorities are not currently funded in Canada.
Successful implementation of all aspects of the National Framework will require additional funding for breast cancer
research as well as some additional investment in infrastructure and capacity development across Canada’s research
system.
The National Framework includes a Call to Action

1. All members of the breast cancer research community are invited to become familiar with the National Framework
document and to work together to achieve the ultimate outcome: a world where no person need fear breast cancer.
2. Breast cancer research funders across Canada are asked to adopt a set of guiding principles2 and to mobilize support
for both foundational research and the identified priorities.
3. Policy and practice influencers are asked to apply existing research findings to policy and practice as they relate to
breast cancer, cancer and chronic disease, and to engage with researchers and academics to shape future studies
aligned with policy development.
4. Industry (e.g., pharmaceutical companies, biotechnology companies, software developers, equipment manufacturers)
is encouraged to participate in new collaborative opportunities.
5. Provincial and hospital foundations are asked to allocate 10 per cent of their funds to these national priorities.
6. Donors are encouraged to familiarize themselves with the National Framework and to request that the organizations
receiving their support embrace these priorities and recommendations.
CBCRA is committed to leading the implementation of the National Framework, and to ensuring it is monitored, updated
and evaluated. As part of this commitment, CBCRA will also facilitate the development of a network of funders aligned
with the National Framework, fostering new collaborations aimed at ensuring the most effective use of resources.
2. SUMMARY
A National Framework for Breast Cancer Research

is needed in Canada at this time
One of every nine Canadian women is expected to develop breast cancer during her lifetime and one in 28 will die
of the disease. In every adult age group, breast cancer is the most common female cancer.3 This is in contrast to men
for whom breast cancer remains rare. While incidence and mortality rates have continued to decline, many Canadians
are concerned because female breast cancer rates in Canada remain among the highest in the world.4 Many important
questions remain unresolved.
The good news is that over the past fifteen years, investment in breast cancer research has seen a twenty-fold increase.
This has led to the development of significant research talent and contributed to breakthrough discoveries. The
opportunity exists to maximize Canada’s contribution to tackling breast cancer globally by leveraging and co-ordinating
current, leading edge, internationally recognized projects. However, to achieve this level of global impact, funders will
need to collaborate more effectively in setting priorities, deploying resources and promoting their strengths.
2
For a listing of these principles see Discussion section in Chapter 6 Identifying the Research Priorities: pg 62.
3
Canadian Cancer Statistics 2009 by the Canadian Cancer Society, Statistics Canada, Provincial/Territorial Cancer Registries and the
Public Health Agency of Canada. Available at www.cancer.ca.
4
Ibid.
Chapter 2: Summary 9.
Members of the Canadian Breast Cancer Research Alliance5 (Avon Foundation for Women – Canada, Canadian Breast
Cancer Foundation, Canadian Breast Cancer Network, Canadian Cancer Society, Canadian Institutes of Health Research,
Health Canada and the Public Health Agency of Canada) determined the need to capitalize on the growth of Canadian
research talent, the widening interest in strategic research investment and the burgeoning knowledge about breast
cancer to undertake an inclusive process to develop a national breast cancer research strategic framework that would
guide all funders of breast cancer research in Canada.
Extensive discussions involving funders, breast cancer patients and survivors, and researchers from across Canada and
internationally, led to the development of the National Framework presented in this document.6
The opportunity is clear: to identify existing and emerging research priorities, areas that maximize Canada’s comparative
advantages and represent the best fit of Canadian initiatives within a larger set of provincial/territorial, regional, national
and international initiatives, and to articulate a call to action. The National Framework builds on foundational elements
already in place. The goal is to harness the existing momentum to increase levels of research impact while using
resources more effectively. By articulating what is most important, the National Framework challenges the breast cancer
community to step forward and act on these agreed priorities.
CBCRA has facilitated the development of the National Framework,

but shares responsibility with other funders to implement it
Championing the process was a natural evolution for the Alliance. Moving forward, CBCRA is committed to the
successful adoption and implementation of the National Framework by the funder community. CBCRA will be updating
and reporting on the priorities on a regular basis.7
The National Framework represents a new paradigm in

research prioritization
The concept of a National Framework builds on the development of national disease state plans such as those for cancer,
heart and diabetes. However, it is novel in its exclusive focus on research and collaboration among funders.
Features defining this new paradigm include:
1. It is strategic in terms of defining priorities and putting in place an updating and monitoring process.8 However,
it is not a strategic plan in the sense that it does not prescribe requirements for any one organization.
2. It provides a balanced portfolio of options, covering all aspects and elements of the breast cancer research
system. Further, some of the priorities identified within the National Framework related to early pillar research
such as genomics and gene-related studies will likely provide insights that will be relevant to other cancer sites.
3. It establishes the groundwork for achieving and measuring high levels of scientific rigour and research impact in
a streamlined manner.
4. It is forward looking, acknowledging the importance of short-term as well as longer-term initiatives. The National
Framework identifies different issues and different approaches to research, recognizing that they will result in
actionable findings over different time periods – and that all are important for a robust research system.
5
Brief overview of the Alliance is provided in Chapter 3: Rationale for the National Framework: pg 17.
6
For more detail see Chapter 5 Approach and Methodology: pg 23.
7
For more detail see Chapter 7 Call to Action: pg 65.
8
Ibid.
10. Chapter 2: Summary

The National Framework identifies areas for high-impact research
The National Framework identifies the continuing need for such foundational elements as investigator-initiated research
across the continuum, clinical trials infrastructure and activity and platforms for innovation such as molecular imaging.9
In addition, it selects a small number of overarching and cross-cutting themes as well as a longer set of refined research
priorities, spanning the cancer continuum. These have been chosen through a rigorous, scientific and inclusive process.
The objective is that, if funded, any of these research areas will benefit Canadians and improve Canada’s global
competitiveness.
The six research themes are:
Includes research on cellular, biological, lifestyle factors; e.g., obesity or other

risk factors and their influence on the risk of developing breast cancer. A better
A. MECHANISMS OF CANCER
understanding of the genetic defects responsible for cancer development
DEVELOPMENT
and of the mechanisms by which external factors promote genetic alterations
could lead to prevention strategies.
Includes research on early detection of breast cancer, including non-
B. MOLECULAR DETECTION AND mammography-based tools, and research into more effective ways to
PREDICTION distinguish between what is breast cancer and what is not, in order to
reduce overdiagnosis. It will also look at linking 3-D imaging to disease and
microenvironment.
Includes research on systemic approach to biomarker validation and gene
C. PERSONALIZED MEDICINE targets, genomic screens, companion studies with treatment links to identify
biomarkers predictive of response to treatment, treatment of recurrent breast
cancer and decision-making tools for treatment of primary disease.
D. CANCER PROGRESSION AND Includes research on markers and predictors of breast cancer progression/
DISSEMINATION metastasis, understanding how to block metastatic pathways, the
identification of which lesions will progress to invasive cancer and on
prediction and prevention of breast cancer recurrence.
Includes research on the psychosocial aspects of breast cancer, such as
interventions to improve quality of life of breast cancer patients throughout
E. PSYCHOSOCIAL, SURVIVORSHIP
the course of the disease, and health-care delivery to breast cancer
AND HEALTH SERVICES
patients. This area includes biomedical and clinical approaches to access,
survivorship and quality of life issues (e.g., late effects).
This cross-cutting theme reflects the intent of the national framework
to ensure that research makes a difference: that evidence is moved
F. TRANSFERRING KNOWLEDGE into practice to the benefit of all Canadians. This theme establishes the
INTO PRACTICE expectation that in all the work that is undertaken as part of the National
Framework, ways are sought to ensure that the best questions are
formulated and funded, that what is known informs the development of
further studies and that when a body of knowledge emerges, it is used to
inform, and possibly change, current practice and policy.
9
For more detail see Chapter 6 Identifying the Research Priorities: pg 33.

At a more detailed level, 17 high impact research priorities across the Common Scientific Outline, an organizing
framework used by the majority of research granting agencies, were identified as outlined below:10
CSO
Research Priority11 Description
Category
Cancer is a disease of the genes. This research priority will focus on
1. GENETICS – The identifying the gene-altering changes underlying cancer initiation and
genetic and epigenetic progression. A better understanding of the role played by genetic and
basis of breast cancer epigenetic changes implicated in breast cancer and the discovery of
development new breast cancer susceptibility genes could lead to better strategies for
cancer prevention and treatment.
Cancer initiation is thought to result from alterations to the molecular
2. INITIATION – machinery regulating the normal functioning of cells. This research
Deciphering the priority will study these alterations and the factors influencing them,
molecular pathways and the consequences of these alterations on breast cancer initiation.
Biology
implicated in breast The results of this research could be highly clinically relevant through
cancer initiation the identification of molecular pathways that could be targeted by new
therapeutic interventions to block cancer initiation.
3. METASTASIS –
Understanding the Metastatic breast cancer results in mortality from the disease and is still
cause of metastatic poorly understood. Therefore, gaining a better understanding of the
breast cancer process of invasion of cancer cells throughout the body is critical and
and identifying should result in the development of new strategies for treatment of
new avenues for metastatic breast cancer.
interventions
4. BREAST CANCER
RISK – The influence
of lifestyle and Research in this priority area will attempt to identify modifiable risk factors
environmental implicated in the development of breast cancer. This could lead to the
factors on the risk of development of new prevention strategies and interventions.
developing breast
cancer
Certain genes or hormonal factors have been linked to the development
5. BREAST CANCER
of breast cancer in some groups of individuals. This research priority
CAUSES I – The
Etiology explores this link in more detail, and could lead to the development of
genetics and hormonal
new interventions or treatments to reduce the risk of breast cancer in
causes of breast cancer
certain populations.
The interaction of genes with lifestyle factors (gene-environment
6. BREAST CANCER
interaction) could play an important role in breast cancer risk. Research
CAUSES II –
in this priority area will study the interaction of different factors, such as
Understanding the
genetic predisposition or exposure to a certain environment on the risk
interplay of multicausal
of developing breast cancer. The results of this research could have an
factors: genetics and
important impact in the development of new breast cancer prevention
environment
interventions.
7. PREVENTION
(INTERVENTIONS) –
Interventions to study Specific factors continue to be identified as influencing the risk
the influence of lifestyle of developing breast cancer, particularly in some subpopulations.
Prevention
and environmental Research in this priority area will aim to develop new population-based
factors on the risk of interventions that could be introduced to reduce breast cancer incidence.
developing breast
cancer
10
For more detail on the Common Scientific Outline and priority setting process see Chapter 3 Approach and Methodology: pg 17.
11
Additional information on each of these Priorities is included in Chapter 6 Identifying the Research Priorities (pg 33) under the following
headings: Current Funding Levels; Current Research Activity; Possible Research Questions; Proposed Investment Requirements;
Readiness to Initiate Research, Timing of Impact, Uniqueness to Breast Cancer and System Support Requirements.
CSO
Category
8. DETECTION – Better This research priority will focus on the development of new approaches
approaches to to breast cancer screening and on the discovery of new tools leading
early detection and to more accurate diagnoses and to more personalized treatment of the
diagnosis disease.
9. BIOMARKERS I –
Development
and evaluation of Research in this priority will lead to the discovery and validation of new
Early
new biomarkers biomarkers. New diagnostic biomarkers will provide critical information for
Detection,
(including biomarkers more accurate disease characterization. Predictive biomarkers will forecast
Diagnosis
for diagnosis) and patient response to therapy and could lead to the development of new
and
the optimization treatment targets.
Prognosis
of treatments for
individual patients
10. BIOMARKERS II – Following the discovery of new biomarkers, clinical trials will be required
Clinical setting/ to assess their use in a clinical setting, particularly for some specific
clinical trials to assess subtypes of breast cancer. The results of these trials will have an important
clinical sensitivity and impact on the development of new personalized therapeutic strategies
specificity of new by providing predictive information on response to therapy for specific
biomarkers groups of breast cancer patients.
11. NEW TREATMENTS –
Discovery and More specific and effective therapies are required for breast cancer
development of new patients. This research priority area will focus on the development of
treatments for breast better treatments, particularly for some specific subtypes of breast cancer.
cancer
Treatment
Following the discovery of new promising therapies, clinical trials and
12. CLINICAL TRIALS – related companion studies test these new agents on breast cancer
Clinical trials of new patients. Clinical testing and applications of new breast cancer therapies
promising therapies and the assessment of side effects, toxicity and pharmacodynamics is a
critical step in the implementation of these therapies.
Research in cancer survivorship covers the range of research domains from

basic biomedical (e.g., to understand the underlying mechanisms leading
to late effects of treatment modalities); clinical (e.g., to test interventions
Cancer
13. SURVIVORSHIP AND to ameliorate late effects; health service interventions to improve the
Control,
QUALITY OF LIFE quality of survivorship care; randomized trials to improve the evidentiary
Survivorship,
INTERVENTIONS – basis for elements of follow-up care during survivorship); and population
and
Psychosocial studies (e.g., to understand the impact of public health interventions to
Outcomes
and survivorship improve lifestyle factors on the outcomes for cancer survivors).
Research
interventions Research in quality of life could lead to the development of new
interventions for improving the quality of life of breast cancer patients
across the course of the disease, and promoting psychological adjustment
to the diagnosis of breast cancer and to treatment effects.
continued...

CSO
Category
This area of research examines quality of care, access to care (including
timeliness and equity), and factors associated with variations in quality
and access. Studies examine the health system requirements to provide
14. HEALTH-CARE ISSUES – optimum quality of care throughout the cancer continuum (from health
Analysis of the financial system requirements to improved screening, reduced wait times for
and health-care diagnosis, and improved end-of-life care). This research also studies
delivery issues facing patients’ preferences and needs through the cancer continuum.
breast cancer patients In addition, individuals affected by breast cancer and their family/caregivers
across the cancer face economic challenges. Research in this area could focus on the financial
continuum implications of a breast cancer diagnosis; it could include an evaluation of the
long-term economic and employment implications for breast cancer patients
and their families. The results of this research could have an important impact
on the development of new health services and care delivery policies.
New initiatives in this area will aim to improve the application of research
15. KNOWLEDGE
Cancer findings into policy and practice and identify which KT interventions
TRANSLATION (KT)
Control, are most effective for breast cancer. An understanding of the barriers to
AND BEST PRACTICES –
Survivorship, and supports for the successful application of research results to breast
Interventions to
and cancer is needed. Research will also identify the most effective strategies
improve knowledge
Outcomes to implement best practices in breast cancer care. This could include the
translation and
Research development of new communication approaches, tools and methods to
disseminate best
(cont’d) facilitate, for example, communicating therapeutic options to patients.
practices in breast
This research could also have an important impact on breast cancer
cancer across the
patients through significant improvement in the translation of research
cancer continuum
findings into new policies.
Linking data collected during clinical trials with administrative health
databases enables long-term studies on survivorship and quality of
16. LINK WITH CLINICAL
life issues related to breast cancer treatment. This form of linkage is
DATA – Developing
potentially powerful because data from clinical trials (where patients have
mechanisms to link
been randomly assigned to treatments and where the precise treatment
clinical trial data
regimens are known) may be linked with administrative health databases
with administrative
providing information about long-term outcomes. For example, a clinical
health databases for
trial conducted in 1990, if linked with administrative health databases
studies on long-term
running to 2005, could provide 15-year, patient-specific information on
outcomes and late
outcomes compared to population controls. Research in this area will
effects
provide critical information for the development of future therapeutic
strategies and better understanding of late effects of treatments.
17. ANIMAL MODELS –
Developing new animal
Scientific and cellular models New animal and cellular models are required to study specific subtypes
Model to study response to of breast cancer and their response to treatment as well as breast cancer
Systems therapeutics and mimic development and invasion.
human breast cancer
development

The National Framework identifies system changes needed to support
successful implementation of research priorities
Changes and improvements to the breast cancer research system are needed to enable the implementation of these
priorities and themes. The more significant system changes identified include: improvements in tissue banking; capacity
training in emerging areas of expertise (such as interdisciplinary expertise, bioinformatics, and biostatistics); improved
infrastructure support including protected time for clinician scientists; cross-sectoral partnerships and higher levels
of collaboration among stakeholders (such as funders, industry, community, policy-makers); and the development of
multidisciplinary networks and consortia (in such areas as stem cells, animal model systems, population health/genetics).12
The National Framework requires a realignment of existing and

some new funding
Data collected by the Canadian Cancer Research Alliance (CCRA) for 2007 (the latest year for which data is available)
suggests that a minimum of $46.8M was spent on breast cancer research that year. This does not include investments
in breast cancer clinical trials or research funded by hospital foundations or smaller voluntary organizations that do not
contribute their data to the CCRA database. Much of the funding was for operating grants but there is no breakdown
available regarding how much was targeted and how much went to funding investigator-initiated research. Investigator-
initiated research continues to receive the major share of research investment, although the general trend appears to
indicate a shifting toward targeted research initiatives.
What can be concluded is that of the 17 priorities,13 one priority was identified as not needing additional funding at this
time and 14 required enabling or additional funding. This provides clear evidence that many of the identified priorities
are already receiving attention and therefore, some of the current research expenditure of $46.8M is already being
applied in an aligned, strategic manner. The remaining two priorities were identified as needing new funding.14 Further,
four priorities contained elements requiring both new and additional funding.15 Therefore, the National Framework
demonstrates a relatively good mix of support to ongoing initiatives while drawing attention to approximately one-third
of the proposed priorities which do not currently receive funding.
Successful implementation of all aspects of the National Framework will require additional funding of breast cancer
research in Canada, but radical change is not required. Some resources can likely be shifted as investment is freed up
from current research priorities or moved from areas that may not have lived up to earlier promise. Additional investments
may also be required in infrastructure across the research system.
The National Framework includes a Call to Action16

The time is now right for these priorities to be collaboratively and strategically addressed. To that end:
document and to work together to achieve the ultimate outcome: a world where no person need fear breast cancer.
2. Breast cancer research funders across Canada are asked to adopt a set of guiding principles17 and to mobilize
support for both foundational research and the identified priorities.
12
A full listing is available in Chapter 6 Identifying the Research Priorities: pg 33.
13
For more detail see Chapter 6 Identifying the Research Priorities: pg 33.
14
[1] Etiology: Understanding the interplay of multicausal factors; genetics and environment and [2] Early Detection, Diagnosis and
Prognosis; Clinical setting/clinical trials to assess clinical sensitivity and specificity of new biomarkers.
15
[1] Biology: The genetic and epigenetic basis of breast cancer development; [2] Biology: Understanding the cause of metastatic breast
cancer and identifying new avenues for interventions; [3] Early Detection, Diagnosis and Prognosis: Development and evaluation of new
biomarkers (including biomarkers for diagnosis) and the optimization of treatments for individual patients; and [4] Treatment: Clinical
trials of new promising therapies.
16
For more detail see Discussion section in Chapter 6 Identifying the Research Priorities: pg 62 and Chapter 7 Call to Action: pg 65.
17
For a listing of these principles see Discussion section in Chapter 6 Identifying the Research Priorities: pg 62.

3. Policy and practice influencers are asked to apply existing research findings to policy and practice as they relate to
breast cancer, cancer and chronic disease, and to engage with researchers and academics to shape future studies
aligned with policy development.
4. Industry (e.g., pharmaceutical companies, biotechnology companies, software developers, equipment

manufacturers) is encouraged to participate in new collaborative opportunities.
5. Provincial and hospital foundations are asked to allocate 10 per cent of their funds to these national priorities.
6. Donors are encouraged to familiarize themselves with the National Framework and to request that the
organizations receiving their support embrace these priorities and recommendations.
CBCRA has committed to playing a leading role in supporting the implementation of the National Framework, as well
as to its ongoing monitoring, evaluation and updating. To that end, CBCRA will itself adopt two priority themes for
implementation as part of Phase IV of the Alliance (2010-2015). In addition, CBCRA will support the development of a
network of funders wanting to embrace the recommendations of the National Framework and to work together in new
ways to prevent and/or mitigate the effects of breast cancer, reduce recurrence and, when not curable, transform breast
cancer from a killer into a chronic disease.

3. RATIONALE FOR THE NATIONAL FRAMEWORK
Setting the Stage

Breast cancer currently commands the highest level of research funding among all cancer sites, and much leading edge
and internationally recognized research is underway across the country. However, female breast cancer rates in Canada
remain among the highest in the world.18 Donors are demanding higher levels of accountability and more co-operation
among funders and researchers locally, nationally and globally. New and different ways of working together are required.
Against this backdrop, the CBCRA Board of Directors,19 prior to entering a new phase of the partnership, embarked
upon a strategic review. The Alliance, a cross-sectoral partnership representing public, private, non-profit and breast
cancer survivor organizations,20 is committed to finding ways to prevent breast cancer, improve survival rates and the
lives of those affected by the disease. Since its inception in 1993, as a recognized leader in breast cancer research in
Canada, CBCRA has awarded more than $197M to 583 breast cancer research initiatives covering a broad range of
topic areas. However, CBCRA’s most recent external expert review panel (Sutcliffe et al, 2007),21 while applauding the
success achieved by the Alliance, also challenged it to become more strategic and proactive in shaping the breast cancer
research landscape.
In September 2007, the Board took action on these review findings and initiated the development of a national
framework for breast cancer research. A working group22 was formed, chaired by Drs. Phil Branton (Scientific Director,
CIHR Institute of Cancer Research at the time) and Moira Stilwell (member, National Board of Directors, Canadian Breast
Cancer Foundation at the time and medical oncologist), and charged with the planning and hosting of a National Breast
Cancer Research Summit as the first major milestone in the development of this National Framework.
Defining the National Framework

The National Framework is:
1. A roadmap to guide the efforts of all members of the breast cancer community in moving breast cancer research
forward: generating new knowledge and encouraging further exploration by building on findings and adopting
new knowledge into policy and practice settings.
2. Inclusive in that it recognizes – and leverages – the foundational elements of the breast cancer research system
that are already in place (such as capacity, infrastructure, partnerships, state of the science globally).
3. Strategic in that it identifies existing and emerging research priorities, areas that build on Canada’s comparative
advantage while representing the best fit of Canadian initiatives within a larger set of provincial/territorial,
regional, national and international initiatives.
4. A call to action.
It is NOT a traditional strategic plan with goals, objectives and timelines for a specific organization or sector. However,
it is similar to a strategic plan in that its adoption and implementation will be monitored and it will remain dynamic:
continuing to shape and be shaped by ongoing discoveries and new knowledge in all aspects of breast cancer research.
18
www.cancer.ca/statistics
19
Membership included in Appendix A.
20
The Alliance is funded by both Members and Friends. Current Members include: Avon Foundation for Women – Canada, Canadian
Breast Cancer Foundation, Canadian Breast Cancer Network, Canadian Cancer Society, Canadian Institutes of Health Research, Health
Canada and the Public Health Agency of Canada. Current Friends of CBCRA include: Breast Cancer Society of Canada, The Cancer
Research Society, CURE Foundation.
21
Membership of the External Expert Review Team: Dr. Simon Sutcliffe, Chair (Vancouver), Dr. Carole Cass (Calgary), Prof. Lesley
Fallowfield (Brighton, U.K.), Dr. Tom Kean (Washington), Support – Dr. Judy Birdsell.
22
Membership included under Listing of Working Groups: pg 5.
Chapter 3: Rationale for the National Framework 17.

Stakeholder Expectations
The value of the National Framework to stakeholders is to define a set of national priorities to guide funding decisions
that will prevent and mitigate the effects of breast cancer, reduce recurrence and, when not curable, transform breast
cancer from a killer into a chronic disease.
Stakeholders23 indicate the need for a national framework that is forward looking and strategic, building on Canada’s
existing strengths. They describe a framework focused on impact to maximize chances of breakthrough research
discoveries by addressing unique opportunities. The framework they want must also be relevant, feasible and
demonstrate scientific excellence. Stakeholders also suggested that the framework be sensitive to international, national
and regional issues and initiatives, and demonstrate flexibility by offering opportunities for cross-sectoral funder
collaboration.
More relevant and timely research, as well as improved efficiencies in the research process, will be achieved through
funders working together. The development of the National Framework is expected to encourage greater co-operation
and co-ordination among the many breast cancer funding and research organizations across Canada to address areas
of research priority. The National Framework will attempt to improve communication and support joint planning efforts
among breast cancer research funding agencies. In addition, it will help meet donor expectations for the most efficient
use of funds.24
A tangible and immediate benefit of the National Framework to stakeholders is providing strategic information to
funding organizations which lessens their need for environmental scanning and initial priority setting during their
planning processes. The National Framework provides a starting set of scientifically rigorous options for strategic
consideration by funders. By applying their own strategic requirements and values to this broad set of priorities, funders
can identify their preferred research areas, resulting in significant savings of time and resources.
Outline of this Document

This document includes an executive summary, summary and a detailed report consisting of seven chapters and
appendices. Following a brief statement of the rationale for developing the National Framework, the context for the
work is outlined in terms of the impact of the disease, funding levels and patterns of breast cancer research. The
strengths and limitations of how breast cancer research is currently conducted in Canada are also included.
The approach and methodology behind the development of the National Framework follow, leading to the outline of the
proposed breast cancer research priorities, the assumptions underpinning these priorities, a suggestion as to how they
can be clustered, and a discussion of what is and is not part of the National Framework. The report ends with a call to
action which includes CBCRA’s commitment to make the National Framework a dynamic and valuable strategic resource
to funders across Canada. Footnotes are provided throughout the text to identify sources, some of which are included in
the appendices but the majority of which are available, as identified, on the CBCRA website (www.breast.cancer.ca).
This entire document is available online at www.nationalframework.ca.
23
Proceedings from the National Breast Cancer Research Summit. Mapping the Future. Toronto: May 26-27, 2008. Available on CBCRA
website at www.breast.cancer.ca/pdf/summit_app/mtf-proceedings.pdf.
24
Data from web-survey conducted in early 2008 as reported in Breast Cancer Research Priorities: A survey of survivors and others
involved in breast cancer. Brian Rush and Nancy Dubois. May 2008. Available on CBCRA website at
www.breast.cancer.ca/pdf/Survey_of_Survivors_and_Others.pdf
18. Chapter 3: Rationale for the National Framework

4. SETTING THE CONTEXT
Overview
Many positive developments in breast cancer research have occurred in the last 10-15 years, such as a twenty-fold
expansion of research support to breast cancer from a reported $2.4M in 199325 to $47M in 2007 (out of a total
investment of $403M dedicated to all cancer research).26 However, despite this increase in investment, female breast
cancer rates in Canada remain among the highest in the world.27 This chapter explores the context within which the
National Framework has been developed, firstly in terms of the effect of breast cancer on Canadians, followed by an
explanation of research funding levels and the strengths and limitations of the current breast cancer research system.
Impact on Canadians
In 2009, it is estimated that 22,700 women and 180 men will be diagnosed with breast cancer. An estimated 5,400
women and 50 men will die of the disease.28 This is a daunting picture. While incidence and mortality rates have
continued to decline in all age groups, probably due to the uptake of screening mammography, a drop in usage of
Hormone Replacement Therapy (HRT) and the adoption of more effective adjuvant therapies, many questions remain
unresolved.
In every adult age group, breast cancer is the most common female cancer, accounting for more than 30% of all new
diagnoses in women aged 20-49 and 50-69. Breast cancer represents 20% of all new cancer diagnoses among older
women.29 It is the leading cancer cause of death in young women, and ranks second and third, respectively, in older
ages. One Canadian woman out of every nine is expected to develop breast cancer during her lifetime. Of those who
develop breast cancer, one in four will die of the disease.
Table 1: Summary Statistics for Breast Cancer in Females, Canada – 2009 (estimates)30
Number of New Cases 22,700
Incidence Rates 102 per 100,000
Per cent of All Cancers in Females 27.8%
Incidence Rank in Females 1*
Number of Deaths 5,400
Mortality Rate 22 per 100,000
* Excluding non-melanoma skin cancer
25
Health Canada. Report on the National Forum on Breast Cancer. Ottawa: Minister of Supply and Services Canada. Catalogue
H39/305/994E, 1994.
26
Canadian Cancer Research Alliance: Cancer Research Investment in Canada, 2007: The Canadian Cancer Research Alliance’s Survey of
Government and Voluntary Sector Investment in Cancer Research in 2007. Toronto: CCRA, 2009.
27
www.cancer.ca/statistics.
28
Ibid.
29
Ibid.
30
Ibid.
Chapter 4: Setting the Context 19.

Funding of Breast Cancer Research31
The total amount of research funding allocated to breast cancer is difficult to quantify as there is no complete database
available. The best available data is found in the Canadian Cancer Research Alliance report on the government
and voluntary sector investment for 2007. Submission of data is purely voluntary with the current report containing
information from 37 organizations funding cancer research. This number includes the largest contributors such as CIHR
and the Canadian Cancer Society. Other investments, such as those from hospital foundations or smaller voluntary
organizations, are not captured.32 Data is also not available on research being conducted for other diseases that might
relate to breast cancer. This information could be of particular relevance in areas such as lifestyle factors influencing
prevention and survivorship, where commonalities exist. Also, in the longer term, with the higher number of breast
cancer survivors, there will be an increasing need to manage co-morbidities.
The CCRA report states that an estimated $403M was invested in cancer research in 2007. More than half (51%) of this amount
is invested in non-site-specific cancer. Of the remaining 49%, breast cancer accounts for the greatest share of the site-specific
investment at 14% ($54.6M).33 Trends over the last four years suggest that breast cancer research funding has increased at a faster
rate than for other cancer-specific sites. The following chart depicts research investment across non site-specific and site-specific cancers.
Figure 1: Cancer Research Investment by Cancer Site
BRAIN $15.1M BREAST $54.6M
COLORECTAL $13.6M
LEUKEMIA $23.7M
LUNG $13.8M
PROSTATE $17.2M
NON-SPECIFIC/ALL SITES $205.2M
OTHER SITES $59.2M
TOTAL INVESTMENT - $402,448,190 FROM 2007 CCRA DATA
31
Data for this section has been provided by CCRA’s most recent survey of Government and Voluntary Sector Investment in Cancer
Research (2007). CCRA has adopted the Common Scientific Outline (CSO) to organize and report on the data. Canadian Cancer Research
Alliance: Cancer Research Investment in Canada, 2007: The Canadian Cancer Research Alliance’s Survey of Government and Voluntary
Sector Investment in Cancer Research in 2007. Toronto: CCRA, 2009.
32
The amount of this funding is not available but is thought to be significant: for example, in 2007, provincial cancer and hospital
foundations received some $42.7M from the Weekend to End Breast Cancer.
33
This total investment figure includes all reported projects with breast cancer weightings in excess of 1% which is the CCRA standard. Else-
where in this report, a total figure of $47M is used. This figure reflects the CBCRA standard of including only breast cancer research project
with a weighting of more than 50%.
20. Chapter 4: Setting the Context

Across the different sectors, the federal government contributes the greatest amount to breast cancer research –
approximately 41% – followed by the voluntary sector, which funds more than a quarter of all breast cancer research in
Canada. Multifunded initiatives, including research funded by CBCRA, account for a further 20%.
The overall pattern of breast cancer research investment across the research spectrum mirrors the overall pattern for
all cancers with the majority of research investment going to biology and treatment. Differences noted include more
investment for breast cancer research in the area of early detection, diagnosis and prognosis, and slightly reduced
investment in biology and treatment as compared to all cancers.
As with all cancers, the largest investment category is biology ($19M for breast cancer), followed by treatment ($9.6M
for breast cancer). Prevention receives the smallest amount of research investment for breast cancer and cancer overall
($0.61M for breast cancer). It should be noted that the CSO classification system defines prevention quite narrowly:
research that might typically be referenced as prevention is included in the etiology category. This is obviously a limiting
factor when interpreting the distribution of research investment according to this classification system.
In reviewing breast cancer investment in greater detail, the following chart shows the allocation of investment by CSO category.
Figure 2: Breast Cancer Research Investment by CSO Category
PREVENTION (interventions) $0.61M
EARLY DETECTION,
DIAGNOSIS &
PROGNOSIS $7.2M
ETIOLOGY
(causes of cancer)
$4.7M
TREATMENT $9.7M
BIOLOGY $19.1M
CANCER CONTROL,
SURVIVORSHIP
& OUTCOMES $4.9M
SCIENTIFIC MODEL SYSTEMS $0.51M
TOTAL INVESTMENT - $46,774,937 FROM 2007 CCRA DATA
A profile of the funding mechanisms to which investment dollars are allocated, as shown in the figure below, reveals that
operating grants34 are by far the most common mechanism for breast cancer research, accounting for $38M (81%) of the
$47M total investment. For all cancers, the dollar amount spent on operating grants is $210.4M (52% of total).
34
Definitions of the different funding mechanisms are included in Appendix C.
Chapter 4: Setting the Context 21.

Figure 3: Breast Cancer Research Investment by Funding Mechanism and CSO Category
($47M) – 2007
$15,000,000
Scientific model systems

$11,250,000
Cancer control, survivorship & outcomes
Treatment
Early detection, diagnosis & prognosis
Prevention (interventions)
$7,500,000 Etiology (causes of cancer)

Biology
$3,750,000
Operating grants Equipment/ Career awards Trainee awards Related support

infrastructure grants grants
Strengths and Limitations of the Current Breast Cancer

Research System35
It is generally agreed that for research to be successful, the underlying system needs to provide the necessary resources
and supports. In the arena of breast cancer research, Canada has a strong foundation on which to build and a history of
willingness to collaborate.
Canada is exceptionally strong in the biomedical (particularly cancer genetics and cancer biology), clinical trials and
health services areas. The letrozole trial is an example of Canadian excellence, where research findings changed
clinical practice almost immediately. Internationally recognized individual research excellence exists across the research
spectrum. From a team or group perspective, the NCIC Clinical Trials Group commands international renown.
The universal health-care system, with population-wide access to health care, combined with Canada’s multiculturalism
offers distinct system advantages. The population-based cancer registries, with some critical changes, provide the
potential for a rich source of data which can be linked with other administrative health databases.
However, two major limitations have been identified; namely, funding/capacity development and the ability to move
the knowledge gained from research into practice. Concerns with respect to funding and capacity building include the
need for greater equity in funding across the research continuum as well as the funding of multidisciplinary team grants.
In addition, there is general acknowledgement that the process of moving new knowledge into policy and practice
is lengthy. This process involves stakeholders beyond the research community, and tends to lack standardization and
evaluation.
35
Definition used for research system: The funding mechanisms, partnerships, infrastructure requirements, key processes (such as
planning and surveillance) and human resources to support a world-class research enterprise.
22. Chapter 4: Setting the Context

5. APPROACH AND METHODOLOGY
Overview
A multi-tiered, multi-stakeholder approach was adopted to consult, identify and define research priorities and the
elements of a National Framework. It was developed in two parts – Part One included the data gathering necessary to
inform the National Summit and the input received from that forum. Part Two included the refinement of the research
priorities based on the views expressed at the Summit, further data gathering and expert scientific input.
The schematic below depicts the different stages in the development of the National Framework, from the
recommendations stemming from the review of CBCRA by the external expert panel and the support of the CBCRA
Board, to the completion of the National Framework document.
Figure 4: Process Overview – Developing the National Framework
2010 2010
National Breast Cancer

Research Framework
2009 2009
Summit proceedings/ National

Post-summit development Framework
Working Group
· International initiatives
· Input from Canadian stakeholders National Breast Cancer
· State of the science papers Research Summit
Summit Planning
2008 Working Group 2008
CBCRA Board
engagement/new vision
CBCRA External Review Report

2007 2007
PART 1 - PREPARATION PART 2 - ESTABLISHING PRIORITIES
The Common Scientific Outline (CSO) was adopted as the organizing framework to classify the stakeholder data and to
shape national breast cancer research priorities.36 It was chosen because it is the system currently used by the majority of
national and international research granting agencies.
This chapter presents an overview of the process undertaken to develop the National Framework. The proposed research
priorities are presented in Chapter 6.
36
The Common Scientific Outline is a classification system organized around seven broad areas of scientific interest in cancer research,
developed by the International Cancer Research Portfolio, a joint initiative of International Cancer Research Partners as
defined at www.cancerportfolio.org/cso.jsp.
Other national agencies that classify research by CSO include CCSRI, CBCF, CIHR and members of CCRA. Internationally, such organiza-
tions as the Wellcome Trust, Medical Research Council, Cancer Research UK and the Breast Cancer Campaign use the CSO classification
as do the American Cancer Society, Susan G. Komen, the National Cancer Institute and the Department of Defense in the U.S.
Chapter 5: Approach and Methodology 23.

Methodology
The breadth and depth of existing knowledge, infrastructure and resources created the need for an integrated, phased
methodology, combining use of existing data with new data gathering, analysis and synthesis, and expert opinion. As
already indicated, two distinct stages in the process occurred, linked by the hosting of a National Summit in May 2008.
In addition to identifying research priorities, information was collected about the critical infrastructural and resource
requirements that enable the pursuit of world-class research. These findings are provided at the end of this section.
Part One: Preparation for the National Summit

Part One included the data gathering necessary to inform the National Breast Cancer Research Summit and the input
received at this forum.
1a. Pre-Summit Data Gathering

International Initiatives
Context for the Canadian data was provided by a review of the following international priority-setting initiatives in breast
cancer research, all of which had been conducted within the preceding 18 months:
• Breast Cancer Campaign’s breast cancer gap analysis and the identification of translational research priority areas (U.K.);37
• International web-based consultation on priorities for translational breast cancer research (Top Ten Project or the
St. Gallen Research Priorities);38
• California Breast Cancer Research Program’s process to identify research priorities relevant to the role played in
breast cancer by the environment and health disparities;39
• U.S. Department of Defense congressionally-directed medical research investment in breast cancer. This is a
highly flexible program, with a vision that is adapted annually and a focus on addressing research gaps through
innovative proposals;40
• A Collaborative Summit on Breast Cancer Research hosted in Virginia, U.S., by key funding agencies including
the Avon Foundation, the Breast Cancer Research Foundation and Susan G. Komen for the Cure. This meeting
was attended by approximately 100 invited participants from across the system, including the private sector.
The conference participants identified several key action items, such as the establishment of a National Breast
Cancer Planning Committee and a commitment to demonstrating more transparency in sharing information and
reporting to the public.41
Input from Canadian stakeholders

As captured in Table 2, data was gathered from such key Canadian stakeholders as researchers, policy-makers, those who
influence policy development, survivors and their families/caregivers, and funding organizations:
37
http://breast-cancer-research.com/content/10/2/R26.
38
http://www.toptenresearch.org/#.
39
http://www.cbcrp.org/sri/
40
http://cdmrp.army.mil/bcrp/default.htm
41
http://www.fnih.org/index.php?option=com_content&task=view&id=445&Itemid=551.
24. Chapter 5: Approach and Methodology

Table 2: Summary of Data Gathered from Key Stakeholders Prior to the National Summit
Stakeholder Method Key Findings Comments

72 participants, representing the
full spectrum of breast cancer
Researchers research, including researchers
(49), representatives of cancer Priorities from SRAW were
Common priorities identified by
a) CBCRA: funding agencies (12), policy- positively received when
both processes include:
Strategic makers (2) and breast cancer presented informally to
• Biomarkers; targeted and tailored
Research survivors (9). the Clinical and Scientific
treatment
Agenda Advisory Board of the
• Improved screening tools and
Workshop Chaired by Drs. William Muller Campbell Family Institute
programs
(SRAW)42 and Tom Hack; facilitated by Dr. for Breast Cancer Research
• Knowledge translation
Ivo Olivotto (RAC Chair). in December 2006.
• Risk reduction/prevention
Informed by State of the Science • Metastatic breast cancer
papers (see below). • Survivorship and psychosocial
interventions
31 structured key informant
• Consideration of marginalized and
b) NCIC – interviews to identify themes
subpopulations.
Breast Cancer (breakthroughs, barriers and
Summit immediate opportunities).
Workshop with 22 participants.

15 semistructured telephone
interviews, from individuals setting
Policy influencers saw the
or influencing policy related to
• Health human resources value of a national breast
breast cancer at different levels
• Service models cancer research strategy
and in different jurisdictions across
Policy • Screening in bringing different actors
Canada. Their involvement in
Influencers43 • Treatment/cure together to facilitate better
the policy development process
• Prevention understanding across the
varied. Overall, good coverage
• Palliation. system and better co-
was attained with respect to
ordination of activities.
geography, subject matter and
interest.
Bilingual web-based survey Need for psychosocial and
instrument based on existing other supports before, during
literature, expert input, plain and after treatment.
language review and rigorous
testing. • Prevention (especially environmental Research needed on alternative
causes and risk factors) and complementary treatment
Survivors, Promoted by 11 breast cancer-
• Screening approaches.
Family related organizations.
• Treatment (especially of metastatic
Members and Appreciation for research done
808 fully completed responses: cancer and the wide range of
Caregivers44 to date but need for more
alternative and complementary
• Overall, respondents younger treatment approaches). collaboration and sharing of
than norm in the population, information among researchers.
but statistically not significant. Concern about slow progress
• Some small regional on many important issues and
differences in the data. need for more focus.
continued...
42
Proceedings from the CBCRA Strategic Research Agenda Workshop: Informing CBCRA on Future Strategic Research Priorities (2008- 2013). Toronto:
December 1-2, 2006. Available on the CBCRA website at www.breast.cancer.ca/pdf/CBCRA_Strategic_Research_Agenda_Workshop_Proceedings.pdf.
See also the Advance reading for National Summit – Researcher Priorities, Pg 59. Available at www.breast.cancer.ca.
43
Data from telephonic interviews conducted in early 2008 as reported in Policy Influencers’ Perspectives on Breast Cancer Research. William E.
Maga. May 2008. Available on CBCRA website at www.breast.cancer.ca/pdf/Survey_of_Policy_Influencers.pdf.
44
Breast Cancer Research Priorities: A survey of survivors and others involved in breast cancer. Brian Rush and Nancy Dubois. May 2008.
Available on CBCRA website at www.breast.cancer.ca/pdf/Survey_of_Survivors_and_Others.pdf.

Stakeholder Method Key Findings Comments
Two complementary data 77% of respondents
gathering approaches: • Risk factors and prevention supportive of developing
• Treatment a national breast cancer
• Web-based survey which • Developing research capacity research strategy.
received a 35% response rate. • Laboratory/basic research.
Funders appeared to want
• 13 in-depth key informant Canada’s breast cancer
interviews. Stratified sample In rating previously identified 19
Funding research to be positioned
representing national, and SRAW priorities, respondents’ highest
Organizations45 within a global context; they
provincial research institutes, priorities and/or areas of concern saw more “megaprojects”
cancer agencies and cancer included: enabled through larger and
foundations. longer grants; and they
• Genetics-related research expected Canada’s assets
In general, different topics • Impact of environmental risk factors (such as the publicly funded
were covered and where there • Increasing the amount of translation health-care system and the
was similarity, this was done research. Expanding the focus of culturally diverse population)
deliberately to delve more metastasis-related research. to be used to better effect in
deeply into specific issues. the future.
State of the Science Papers

In preparation for the Strategic Research Agenda Workshop, CBCRA Research Advisory Committee members and other
experts in specific areas of breast cancer research were asked to prepare summary documents describing the “State of
the Union” of breast cancer research in the following areas. These papers were updated for the National Summit and
presented as part of the advance reading materials.
Table 3: List of State of the Science Papers – May 200846
Research area Examples of possible research topics Author

Mammography screening
Early detection Dr. Martin Yaffe
Alternative methods of detection
Genetic predisposition
Epidemiology/Prevention Dr. Norman Boyd
Risk factors (modifiable and non-modifiable)
Health services/ Evaluation of screening programs
Drs. Lisa Schwartz
Knowledge translation/ Knowledge translation of research results into
and Eva Grunfeld
Policy/Ethics policy and practice
Molecular biology and signal Biology of breast cancer development and
Dr. John Hassell
transduction progression at the cellular and molecular level
Prognostic and predictive indicators
Molecular pathology Dr. David Huntsman
Tumour banks
Psychosocial support and group therapy
Psychosocial oncology Drs. Mary Jane Esplen and Tom Hack
Decision making and decision aids
New drugs and vaccines
Treatment and clinical trials Dr. André Robidoux
Radiotherapy and surgical techniques
Tumour microenvironment Breast cancer invasion
Dr. Shoukat Dedhar
and metastasis Angiogenesis
45
Breast Cancer Research Priorities: A survey of organizations funding breast cancer research in Canada and related key informant
interviews. Brian Rush and Nancy Dubois. May 2008. Available on CBCRA website at www.breast.cancer.ca/pdf/Survey_of_Funders.pdf.
46
Papers available as part of the advance reading materials for the National Summit at www.nationalframework.ca.

Data Gathering Limitations
As outlined earlier, it was decided to use an organizing framework (the Common Scientific Outline) which, like any
framework, has its strengths and limitations. One of the most significant concerns that emerged was the absence of a
strong focus on later pillar research areas with almost all population health and health services elements being bundled
in one category (Category 6: Cancer Control, Survivorship and Outcomes). As already mentioned, a narrow definition for
prevention (as predominantly interventions) is used, possibly resulting in more projects falling into the etiology category.
Further, imposing a classification on data not initially collected in that manner can be challenging.
Summarizing the Pre-Summit Proposed Research Priorities

Each workshop and stakeholder survey generated a wealth of information which was synthesized and presented to
delegates at the National Summit.47 Our intent is not to duplicate that effort here. Rather, a snapshot of the common
research priorities from the perspectives of different stakeholders is presented below.
Table 4: Summary of Consolidated Findings from Stakeholder Input – Prior to the National
Summit, May 2008
Listing of
CSO
Prioritized CSO Code Examples of Identified Research Issues/Questions Stakeholders
Category Prioritizing this Code
1. 1.4 Cancer • Early detection of metastasis disease, if oligometastatic Researchers: SRAW,
Biology progression and disease is treatable with curable intent NCIC Summit
metastasis • Does the ability to metastasize develop during
growth at the primary site? Survivors
• Tumour dormancy
Funders
• Risk/prevention of recurrence; why recurrence
after five years?
• Finding new ways to ensure that cancer that
spreads to other parts of the body is found early
2. 2.1 Exogenous factors • Exposure to risk factors: biomarkers of exposure to risk Researchers: SRAW,
Etiology in the origin and cause factors (environment) through long-term cohort studies NCIC Summit
of cancer • How does the food we eat, body weight and
exercise relate to the risk of breast cancer? Survivors
• Why is breast cancer among young/pre-
Policy-makers
menopausal women increasing?
• What are the key causes of breast cancer generally Funders
across the population and within certain cultural groups?
• Lifestyle influence on breast cancer: How do Researchers: SRAW,
nutrition/lifestyle/natural remedies influence NCIC Summit, CBCF
cancer formation, cancer progression and BC/Yukon Region 2020:
3.1 Interventions effectiveness of therapy at the molecular level,
to prevent cancer: The Future Without
including in subpopulations? Breast Cancer Report
personal behaviours • Exposure to risk factors: What biomarkers of
3. that affect cancer risk exposure to risk factors (environment) could be Survivors
Prevention identified through long-term cohort studies?
3.2 Nutritional science Policy-makers
• What insights could be gained through clinical
in cancer prevention
prevention trials in genetically high risk women?
• What are the significant behavioural interventions Funders (Prevention
3.3 Chemoprevention a current priority with
to reduce risk?
• What population-based interventions can be environmental causes seen
introduced to reduce breast cancer incidence? as an emerging priority)
continued...
47
Ibid.

Listing of
CSO
4. 4.1 Technology • Biomarkers: identification of the molecular basis/ Researchers: SRAW,
Early development and/or biomarkers of progression, to target therapies or NCIC Summit, CBCF
detection, marker discovery imaging and to understand and predict progression BC/Yukon Region 2020:
diagnosis • Breast cancer subtypes: Better appreciation of the The Future Without
and 4.2 Technology and/ functional meaning of breast cancer subtypes (e.g., Breast Cancer Report
prognosis or marker evaluation “triple negative” breast cancer) and implications for
with respect to breast cancer progression and for treatment across Survivors
fundamental populations
parameters of method Funders (Early
• Lifestyle influence on breast cancer: How do
detection a current
nutrition/lifestyle/natural remedies influence cancer
4.3 Technology and/ priority with genomics
formation, cancer progression and effectiveness of
or marker testing in a seen more as an
therapy at the molecular level?
clinical setting emerging priority)
• Better screening tools, including for genetically high-
risk women
• Molecular imaging
• Alternative detection methods such as serum-based
markers
5. 5.1 Localized • Better defining therapy needs for individual patients: Researchers: SRAW,
Treatment therapies: discovery more targeted and better tailored interventions NCIC Summit, CBCF
and development • Microenvironment of metastatic breast BC/Yukon Region 2020:
cancer: therapy for metastatic breast cancer The Future Without
5.2 Localized targeted at interaction between tumour and its Breast Cancer Report
therapies: clinical microenvironment
applications • Better appreciation of the functional meaning of Survivors
breast cancer subtypes (e.g., “triple negative”
5.3 Systemic therapies: Funders (Targeted
breast cancer) and implications for treatment across
discovery and therapies and
populations
development Genomics seen as
• Phase I and II intervention trials: focus on multicentre
Emerging Priorities)
5.4 Systemic therapies: Phase I and II trials to test novel paradigms for
clinical applications intervention
• Research on the treatments for cancer that spreads
to other parts of the body (metastatic breast cancer)
• Research on new therapies (such as vaccines and
gene therapies) and new surgical and radiation
treatments
• Research on hormonal therapy (such as tamoxifen)
continued...

Listing of
CSO
6. 6.1 Patient care and • Knowledge translation interventions: Knowledge Researchers: SRAW,
Cancer survivorship issues transfer: increase knowledge about interventions, NCIC Summit, CBCF
control, what works, what doesn’t, studies of uptake and BC/Yukon Region 2020:
survivorship 6.4 Cost analyses and effectiveness on the interventions where evidence The Future Without
and health-care delivery exists Breast Cancer Report
outcomes • Survivorship and Quality of Life intervention
6.5 Education and Survivors
research: better understanding of issues and
communication Policy-makers
design of interventions
• Support across the course of the disease,
Funders (Translational
including post-treatment complications (e.g., pain,
Research and
lymphedema), stress management, mental health
Evaluation of
and reintegration issues, body image, self-esteem,
Supportive Care
for patients and their family/caregivers
described as Current
• Studying the social influences on behaviour
Priorities with Health
related to breast cancer
Services/New Models
• Financial issues/aid (e.g., child care; employment
seen more as an
insurance)
Emerging Priority)
• Health-care delivery: Need for more co-
ordination or communication between players
and in hospitals; more clinical teams and fewer
individual physicians (decreased chances of errors;
opportunity for second opinion)
• Research into plans and policies that will ensure
there are enough trained health-care professionals
for treatment and support
• Inequities: inequities and social determinants,
equitable access to anticancer drugs across the
country
• What is the ranking in terms of cost-effectiveness
of new technologies relative to the most broadly
used current technologies?
• What population-based interventions can be
introduced to increase percentage of women
screened?
• The physical and psychological impact of wait
times on patients
• Within an integrated population-based approach
to reducing cancer or chronic disease, what niche
activities related specifically to breast cancer are
still required?
• Effective messaging about personal risk reduction
7. 7.1 Development and • Animal models of breast cancer progression Researchers: SRAW
Scientific characterization of • Breast cancer modelling
model model systems
systems

1b. National Breast Cancer Research Summit (National Summit)
The National Summit was a pan-Canadian, invitational gathering of stakeholders held on May 26-27, 2008 in Toronto.
Summit participants included representatives from cancer care agencies, cancer foundations, non-government
organizations with a cancer research mandate, provincial and federal health research funding organizations, health
research agencies and research institutes, as well as researchers, policy-makers, survivors and breast cancer community
leaders at regional and national levels. About 75 of Canada’s leading breast cancer research stakeholders, together
with prominent international breast cancer representatives gathered with a goal to determine a more strategic and
efficient path forward. They discussed the current state of breast cancer research, established national research priorities,
identified synergies and agreed on the elements of an optimal pan-Canadian framework.
Priority Setting at the National Summit

A combination of presentations, small group work and plenary sessions allowed participants to discuss issues, challenge
the data and present opinions. Presenters described the breast cancer research community as seeking a comprehensive
framework that included not only sustaining important current research but identifying new or improved investment in a
number of priority areas.
The following research priority areas were identified for possible inclusion in the National Framework:
• Early diagnosis/Detection: put in place an inexpensive, universal screening tool like a blood test, a “fingerprint
of high risk”. Follow up results, if needed, with a more targeted and expensive test. Importance of imaging
leveraging off the current One Millimetre Cancer Challenge program; research into improving screening
compliance; enhance understanding of molecular basis of early disease.
• Etiology/Prevention/Risk reduction: cancer cannot be prevented without knowing its cause, so focus on cancer
genome: determining this can be used as a prescription for prevention; focus on the types of breast cancer
occurring in young women; learn more about implications of breast density; find new ways to combat the
challenge of changing behaviours around certain areas; growth factors/estrogen: how can exposure to estrogen/
growth factors be reduced and lifestyle modulated; include children in the cohort and take advantage of the data
gathered by the cohort.
• Treatment: personalized medicine – reduced toxicity; biological research into metastatic disease; prevention and
treatment of recurrence; understanding of the the role of cancer stem cells; addressing specific issues like triple
negative breast cancer; improving translational science.
• Supportive/Palliative/Psychosocial: is this a cancer or breast cancer issue? What is unique to breast cancer and
should be included within the priorities – perhaps the focus on young women?
• Health services: access to care and to clinical trials – understand the barriers to turning research findings into
action; challenge of timely care.
• Knowledge translation: how to turn results into change; modelling of barriers to the application of knowledge
into practice; moving to evidence-informed practice.
A significant outcome of the National Summit was affirmation of CBCRA’s leadership role in the continued development
of a national breast cancer research framework.
Research System Gaps and Challenges

A further important outcome was the identification of the changes that would be needed to the research system for more
world-class research to be conducted in Canada.
It is generally agreed that for research to be successful, the underlying system needs to provide the necessary resources
and supports. Hence the data gathering undertaken by CBCRA also sought to document the systemic changes required in
order for a national framework to be implemented successfully. Researchers at the CBCRA-hosted SRAW workshop were
asked to select what they saw, moving forward, as the key gaps and barriers to the implementation of successful research.
These questions were also posed to different stakeholder groups to build a broad and consolidated picture. In addition,
a focus group of pre-eminent scientists was convened under the leadership of Drs. Martin Yaffe and Pascale Macgregor
in November 2007.

At the National Summit, delegates identified the importance of addressing the following system issues in order for the
research priorities to be implemented successfully:48
• Introduce closer collaboration across all sectors in the system.

• Improve translational science including national standard operating procedures (SOPs), shared testing of
hypotheses at basic and clinical research levels and the rapid clinical validation of new treatments and predictors
of activity through clinical trials.
• Improve national infrastructure, including quality collection and banking of tumour tissue, serum and blood; the
integration of electronically linked administrative and research databases; resolving ethical and legal challenges;
and a stronger clinical trials infrastructure (national and international) with a broadening of trials to include
prevention and survivorship.
• Improve human resources: developing excellence through funding and recognition approaches.
• Introduce innovative funding mechanisms, including creating more flexibility and introducing a single peer
review process.
• Develop the political will to make these changes, including better public policy, eliminating provincial boundaries
and strong advocacy for research and participation in clinical trials.
Part Two: Establishing Priorities Following the National Summit

Subsequent to the Summit, the CBCRA Board agreed to continue to lead the work necessary to bring the National
Framework to fruition, drawing on a new working group of acknowledged experts with the mandate to provide advice on
the refinement of research priorities and the development of the overall National Framework.
2a. Creating a National Breast Cancer Research Framework Working Group

The National Framework Working Group (NFWG) was formed at the end of the summer of 2008, to complete the task
of reaching agreement on the research priorities.49 Dr. Morag Park, a current member of the CBCRA Board, and Dr. Eva
Grunfeld, a past member of the Research Advisory Committee, agreed to act as co-chairs. This 16-person group of
highly respected research leaders was selected based on individual scientific expertise across the cancer continuum and
represented a range of geographic areas across the country.
2b. The National Framework Working Group in Action

NFWG embarked upon a rigorous and fast-paced seven-step process, building on the existing work, to:
1. Confirm current and emerging initiatives in breast cancer and cancer at the national and international levels;
2. Define research themes or priorities and possible research questions by CSO category;
3. Identify possible funding mechanisms and order of magnitude funding requirements;
4. Establish the nature of the funding required (whether current funding should be sustained, expanded or enabled,
or new funding initiated);
5. Determine required research system and infrastructure supports;
6. Assess the priorities according to their uniqueness to breast cancer, the readiness in Canada to undertake the
research, and the timing of expected impact of the research;
7. Identify overarching themes or clustered priorities that span CSO categories.
48
A full listing is available in the Proceedings from the National Breast Cancer Research Summit. Mapping the Future. Toronto: May 26-27,
2008. Available on CBCRA website at www.breast.cancer.ca/pdf/summit_app/mtf-proceedings.pdf.
49
Membership included under Listing of Working Groups: pg 5.

Further data gathering was required to inform the above work. An international scan was conducted to identify current
and emerging research programs in breast cancer and cancer, primarily in Europe, the U.K., North America and Australia.
A national scan to identify similar Canadian current and emerging research programs was also undertaken. NFWG
members, familiar with current and emerging efforts, both nationally and internationally, validated and added to the data
to provide comprehensive coverage across the cancer spectrum.
Several separate analyses were also conducted by CCRA using its database, to further define breast cancer research
funding by CSO category and code.
NFWG met three times as a group in October and November 2008. Given the complexity and level of detail required,
the process also included a series of small group teleconference calls or one-on-one telephone interviews with working
group members. These meetings focused specifically on the research theme(s) relevant to the scientific expertise of
each working group member, allowing for meaningful engagement. This process generated a more in-depth discussion
between group members, facilitating a careful review of the material and proposed research priorities.50 Consensus
on the list of research priorities was achieved and validated at the final meeting of NFWG, held on January 20, 2009.
NFWG then went a step further with the list of individual priorities, relaxing the CSO framework to cluster priorities into
research themes. Finally, NFWG reviewed the list of research system gaps and challenges generated at the National
Summit, refining the list to include system gaps relevant to the identified priorities. These system gaps are included in
the descriptions of each research priority in Chapter 6.
50
Between December 3 and 18, 2008, nine small group meetings and five one-on-one interviews were held with NFWG members and
CBCRA’s Executive Director and Research Program Director. The majority of NFWG members participated in more than one meeting
addressing several thematic research areas. The results of these in-depth meetings were tabulated for the fourth teleconference
meeting of NFWG.

6. IDENTIFYING THE RESEARCH PRIORITIES
Overview
This chapter showcases the work of the National Framework Working Group in finalizing the National Framework,
building on the findings from Part One, including the proposals developed at the National Summit.
It begins by acknowledging the foundational system elements that need to be maintained if breast cancer research is
to thrive in Canada. It goes on to present the research priorities, first individually and then clustered as priority research
themes. Each research priority is described in terms of a number of elements reflecting the criteria used in selecting and
assessing them. The chapter concludes with a summary of the required research system changes and a discussion of the
possible funding and other ramifications arising from the National Framework.
Foundational Elements of the Breast Cancer Research System in Canada

Capacity to perform world-class breast cancer research in Canada has been built up over the years and was given a
significant boost with the founding of CBCRA in 1993. A broad foundation is now in place that has enabled many critical
discoveries.
In discussions around setting priorities for future research, it was explicitly acknowledged that the foundational elements
need to continue to ensure the sustainability of future breast cancer research. Most of these underlying elements are not
exclusive to breast cancer research. However, the challenge from a funding standpoint lies in trying to determine the
relative level to invest in such foundational mechanisms as:
1. Investigator-initiated grants across the spectrum of breast cancer research; i.e., there is a need for robust open
competitions beyond the priorities and strategic research identified by funders.
2. Clinical trials infrastructures including not only cancer treatment centres but national or other groups outside of
industry.
3. Platforms for innovation: examples might include biomarker development, molecular imaging and cohort studies.
While the total investment in non-industry-funded clinical trials is known, the portion that is breast cancer specific is not
available at this time. Similarly, while funding levels of operating grants by CCRA survey participants are known, those
related to targeted competitions are not tracked. However, a trend toward more targeted research is clearly evident, with
the scientific community expressing a view that the optimal investment ratio between investigator-initiated research and
targeted research is in the range of 70:30.
Research Priorities by CSO Category

Significant background data supported the selection of each breast cancer research priority (including input from
different stakeholders gathered before and during the National Summit; identification and collation of internationally
determined priorities, current and emerging funded research projects in Canada and internationally). NFWG considered
all of this information and through further rigorous discussion identified the following 17 research priorities. They are
presented below by CSO category and are described in terms of their CSO code,51 the types of research questions
considered interesting and important, and the current level of activity together with proposed new funding requirements
and mechanisms.52
A detailed breakdown of current funding by CSO code is provided as Appendix B.

51
Initiate: New investment is needed to encourage research in this area.

52
Enable: Some funding is currently directed to research within this CSO code, but additional funding is required.
Sustain: Funding currently in place that needs to be continued.
Chapter 6: Identifying the Research Priorities 33.

CSO Category 1: Biology
1. The genetic and epigenetic basis of breast cancer development

(linked to CSO code 1.2)
Cancer is a disease of the genes. This research area will focus on identifying the gene-altering changes underlying
cancer initiation and progression. A better understanding of the role played by genetic and epigenetic changes
implicated in breast cancer and the discovery of new breast cancer susceptibility genes could lead to better
strategies for cancer prevention and treatment.
Current Funding Levels
The most recent CCRA data identifies that only 2.8% of total funding to breast cancer research is dedicated to this area
of research, primarily through operating grant programs (79%).53
Current Research Activity
No current or emerging initiatives specifically for breast cancer were identified in Canada or internationally. Identified
cancer-wide initiatives include: the Ontario Institute for Cancer Research Stem Cell Project (GENESIS) and the California
Institute for Regenerative Medicine/CIHR ICR collaboration on cancer stem cell research.
Internationally, for breast cancer specifically, the National Cancer Institute (NCI) has funded an RFA on the biology
of breast pre-malignancies, up to $4.5M (2008-2010). In Australia, the Priority-driven Collaborative Cancer Research
Scheme (PdCCRS) receives about $10M of funding from Cancer Australia and the National Breast Cancer Foundation
(NBCF). Projects are in place investigating all cancers in the EU, Sweden and the U.S.
Possible Research Questions
Examples of types of research within this area of enquiry include:
• What is the role played by tumour-initiating cells?

• What are the new cancer susceptibility genes and mutations associated with different subtypes of breast cancer?
• What is the role played by epigenetic changes in tumour initiation and progression?
• What is the impact of chromosomal integrity in breast cancer initiation?
Proposed Investment Requirements
This area was identified as needing new and more investment to encourage research (initiate and enable) through
mechanisms such as a broad competition directed to breast and other cancer tumour-initiating cells. This competition
would include the opportunity for the funding of small teams and specific targeted initiatives, such as the impact of
chromosomal instability on breast cancer development. An amount of $5-10M over five years was proposed for each of
the suggested funding mechanisms, for a total of $20M.
53
The CCRA data does not distinguish between investigator-initiated research and targeted research. Thus, the percentage provided
includes grants from both types of competitions.
34. Chapter 6: Identifying the Research Priorities

Other Characteristics
1. Readiness to Initiate Research: As there is significant researcher expertise and capacity in Canada and Genome
Canada has invested in substantial infrastructure, this area has a high degree of readiness to initiate research.
2. Timing of Impact: Research is likely to have a medium-term impact (five to 10 years) on patient health and the
health system.
3. Uniqueness to Breast Cancer: The nature of the results (e.g., which gene) will determine whether they are unique
to breast cancer.
System Support Requirements
Specific areas where improvements or changes are required to the research system to enable success include:
• Infrastructure for cancer genome sequencing;

• A co-ordinated and systematic approach to specimen collection and annotated clinical information;
• Capacity training in bioinformatics and encouraging research teams to include bioinformaticians;
• Support to international networks.
2. Deciphering the molecular pathways implicated in breast cancer initiation

Cancer initiation is thought to result from alterations to the molecular machinery regulating the normal functioning
of cells. This research priority will study these alterations and the factors influencing them, and the consequences of
these alterations on breast cancer initiation. The results of this research could be highly clinically relevant through the
identification of molecular pathways that could be targeted by new therapeutic interventions to block cancer initiation.
The CCRA report determined that 15.4% of total breast cancer funding is currently targeted to this area of research,
primarily through operating grants (73%) and personnel awards (16%).
One initiative identified within Canada specifically for breast cancer, was for research awards from the Translation
Acceleration Grants for Breast Cancer Control program (a $6.6M CBCRA/CIHR program to be completed in 2009). The
OICR GENESIS program is applicable to breast cancer. The Terry Fox Research Institute’s (TFRI) project grants may also
be applicable.
Internationally, for breast cancer specifically, NCI has funded an RFA on the biology of breast pre-malignancies, up to
$4.5M (2008-2010). In Australia, the PdCCRS receives funding of about $10M from Cancer Australia and NBCF. For
cancer generally, several initiatives were identified from the EU, Finland and from NCI in the U.S.

• What are the effects of hormones and growth factors and their receptors in breast cancer development?
• How are normal control mechanisms (e.g., senescence) bypassed during tumour initiation?
• What is the clinical relevance of novel breast cancer stem cell biomarkers?
This area was determined to require additional investment (enable) given that the CBCRA/CIHR TAGS projects are
funded only until 2009. An amount of $22M has been proposed to finance a portfolio of funding mechanisms over the
next five years. These include a specific RFA on Translation Acceleration Grants (team grants) for $5-7M over three to five
years; encouragement of operating grants in this area (e.g., by funding the top grants through a priority announcement)
for $2M annually; and launching an open competition for small teams (two or three Principal Investigators) and existing
teams for $2-3M per year.
1. Readiness to Initiate Research: Given the current international excellence, this area has a high degree of
readiness to initiate research.
2. Timing of Impact: Research is likely to have a short-term, as well as a medium- to longer-term impact (5+ years)
on patient health and the health system.
3. Uniqueness to Breast Cancer: Research results will represent a combination of insights, some of which will be
unique to breast cancer.
Specific areas where improvements are required to the research system to enable success include:
• Tissue banks: Infrastructure to collect high quality samples from all patients, with access to appropriate and
annotated clinical material;
• Access to and management of tissue microarrays and similar methods/data sets, and their associated patient
databases;
• Capacity building and training to integrate systems biology and bioinformatics (e.g., student and post-doc
fellowships, networks with leading centres for internships);
• Career system for retaining bioinformaticians.
3. Understanding the cause of metastatic breast cancer and identifying new avenues for
interventions (linked to CSO code 1.4)
Metastatic breast cancer results in mortality and is still poorly understood. Therefore, gaining a better understanding
of the process of invasion of cancer cells throughout the body is critical and should result in the development of new
strategies for treatment of metastatic breast cancer.

The most recent CCRA data identifies that approximately 19.5% of total breast cancer research funding is dedicated to
this area of research, primarily through operating grant programs (84.2%).
Current and emerging breast cancer specific projects include CBCRA’s New Approaches to Metastatic Disease in Breast
Cancer, in partnership with CBCF and the Cancer Research Society (CRS), for $7M total (2005-2010) and the CBCRA/
CIHR-funded Translation Acceleration Grants for $6.6M total (2005-2009). Addressing all cancers are the OICR Cancer
Stem Cell Project ($17M for three years) and a planned CIHR cross-institute RFA addressing, among other areas, the
tumour microenvironment.
Internationally, for breast cancer specifically, NCI has funded an RFA on the biology of breast pre-malignancies, up to
$4.5M (2008-2010). In Australia, the PdCCRS receives funding of about $10M from Cancer Australia and NBCF. For
cancer generally, several initiatives were identified from the EU, Belgium and from NCI in the U.S.
• Does the ability to metastasize develop during growth at the primary tumour site?
• What are the mechanisms of tumour dormancy and reactivation?
• What is the basis for homing to different tissues?
This area was identified as needing new and additional investment to encourage research (initiate and enable). While
some areas have received funding, key questions in other areas are not currently funded.
Researchers determined a need for approximately $20M over the next five years to fund two specific initiatives:
encouraging operating grants in this area (funding top grants through priority announcement) ($5M over three to five
years) and a specific RFA (team grant) on metastatic mechanisms in breast cancer ($15M over three to five years).
1. Readiness to Initiate Research: With its current level of activity, this area has a reasonable degree of readiness to
initiate research.
2. Timing of Impact: Research is likely to have a short-term, immediate and longer-term impact (5+ years) on
patient health and the health system.
3. Uniqueness to Breast Cancer: Research results will not be unique to breast cancer.
Specific areas where improvements are required to the research system to facilitate success include:
• Tissue banks: Infrastructure to collect high quality, annotated clinical material samples (including metastases and live
cancer stem cells) from all patients;

• Development of and access to tissue microarrays;
• Development of new animal models (cross reference to CSO code 7.1);
• Capacity building in emerging areas of expertise; e.g., pathology.
CSO Category 2: Etiology (Causes of cancer)
4. The influence of lifestyle and environmental factors on the risk of developing

breast cancer (linked to CSO code 2.1)
Research in this priority area will attempt to identify modifiable risk factors implicated in the development of breast
cancer. This could lead to the development of new prevention strategies and interventions.
The most recent CCRA data shows that about 2.1% of total breast cancer research funding is dedicated to this area of
research, primarily through operating grant programs (84%).
CBCRA funded 10 projects in an Etiology/Primary Prevention research program for $9.25M. These projects ended
in 2006. Two major emerging initiatives are focusing on all cancers: the CCS Prevention Initiative which addresses
modifiable risk factors and conditions in cancer prevention and the National Cohort Study of 300,000 participants,
funded for $100M by the Canadian Partnership for Tomorrow Project (CPAC, OICR, Alberta and CARTaGENE).
Internationally, for breast cancer only, a U.S.-based foundation, Susan G. Komen for the Cure, is funding a few studies
(ductal carcinoma in situ [DCIS], experimental model systems, identification and validation of biomarkers, and the
development of environmental research methods). NCI is co-ordinating two other studies.
Several international studies are taking place for all cancers: in France, Germany, the U.K. and the U.S., as well as by a
group from the U.K., France, Hong Kong and the Netherlands. These projects are researching the link between cancer
and diet, physical activity and weight management.
• Which lifestyle and environmental factors offer the greatest potential for influencing risk?
• What are the key causes of breast cancer generally across the population and within certain cultural groups?
• Why is breast cancer among young/pre-menopausal women increasing?
• What is the interrelationship between obesity and the risk of breast cancer?
It was decided that this area requires an ongoing investment similar to its current funding level (sustain). Several funders
(as outlined above) have already selected significant initiatives that will include breast cancer requirements. Therefore
the proposed approach is to partner with agencies such as CPAC on its Canadian Partnership for Tomorrow Project to
monitor progress within the National Cohort Study, and to identify which findings are relevant to breast cancer. This
process will help to identify breast cancer-specific projects on an as-needed basis.

1. Readiness to Initiate Research: With its current level of activity this area has a high degree of readiness to initiate
research.
2. Timing of Impact: Research is likely to have a medium- to longer-term impact (5+ years) on patient health and
the health system due to the anticipated length of time required to complete the cohort recruitment.
3. Uniqueness to Breast Cancer: Research results will represent a combination of insights, some of which will be
unique to breast cancer.
No specific areas requiring improvements were found. However, once the cohort recruitment is completed, additional
funding will be needed for questioning the cohort findings. Funding at a later date could support the ability to carry out
targeted sequencing and research on new animal models.
5. The genetics and hormonal causes of breast cancer (linked to CSO code 2.2)
Certain genes or hormonal factors have been linked to the development of breast cancer in some groups
of individuals. This research priority explores this link in more detail, and could lead to the development of new
interventions or treatments to reduce the risk of breast cancer in certain populations.
The most recent CCRA data shows that approximately 6.4% of total breast cancer research funding is dedicated to this
area, through a combination of operating grant programs (74.2%) and personnel awards (18.8%).
No current or emerging breast cancer specific initiatives have been identified. Two major emerging initiatives are
focusing on all cancers: the CCS Prevention Initiative which addresses modifiable risk factors and conditions in cancer
prevention and the National Cohort Study of 300,000 participants, funded for $100M by the Canadian Partnership for
Tomorrow Project (CPAC, OICR, Alberta and CARTaGENE).
Internationally, for breast cancer only, NCI has funded the Cancer Genetic Markers of Susceptibility Initiative (CGEMS).
An international Breast Cancer Family Registry Project (BCFRP), currently in Phase 3, is being developed. Cancer Care
Ontario is a member of this initiative. Many international studies are underway, focusing on all cancers. A $20M study
involving specimens from approximately 500 patients is taking place in the EU, France, Finland, the U.K. and the U.S., as
well as with two international consortia. OICR is a member of this group. The international HapMap Project is developing
a haplotype map of the human genome at a cost of $100M, with Genome Canada as a member.
• What is the role played by certain genes or factors (sex steroid hormones, obesity and inflammation markers,
molecular markers of disease occurrence, etc.) in familial and sporadic breast cancer biology?
• What are specific polymorphisms and specific genes that will influence breast cancer risk in specific populations?

It was decided that this area needs more investment to encourage research (enable) since, with the exception of the
National Cohort Study, which is not breast cancer specific, no other initiatives specific to breast cancer are in place.
Researchers indicate that this area of research requires about $9M in investment over the next five years. This amount
would be used for targeted RFAs such as the Translation Acceleration Grants addressing the deciphering of molecular
pathways implicated in cancer initiation ($5-7M over three to five years – the same RFA listed under CSO Code 1.3),
developing Canadian involvement in international cohorts ($1-2M over two years) and ongoing partnering with the
Canadian Partnership for Tomorrow Project to ensure breast cancer-specific data is collected and made available.
1. Readiness to Initiate Research: With the current level of activity this area has a high degree of readiness to initiate
research.
the health system.
3. Uniqueness to Breast Cancer: Research results will be a combination of insights, some of which will be unique to
breast cancer.
Specific areas where improvements or changes are required to the research system to facilitate success include:
• Capacity training in emerging areas of expertise; e.g., bioinformatics and biostatistics;
• Once recruitment for the cohort is completed, additional funding will be needed to include specific questions of
the cohort study. Funding needed at a later date could support the following:
o Access to cohort materials;
o Ability for targeted sequencing;
o Development of new animal models;
o Technology for functional validation (e.g., RNAi) of genes discovered through cohort studies.
6. Understanding the interplay of multicausal factors: genetics and environment

The interaction of genes with lifestyle factors (gene-environment interaction) could play an important role in breast
cancer risk. Research in this priority area will study the interaction of different factors, such as genetic predisposition
or exposure to a certain environment, on the risk of developing breast cancer. The results of this research could have
an important impact in the development of new breast cancer prevention interventions.
The most recent CCRA data shows that approximately 1.5% of total breast cancer research funding is dedicated to this
area of research, primarily through operating grant programs (88.8%).

No current or emerging breast cancer-specific initiatives have been found. The CCS Prevention Initiative addresses all
cancers, focusing on modifiable risk factors and conditions in cancer prevention. However it is not clear at this time
whether research in this area will be funded or whether such research would be specific to breast cancer.
Internationally, studies exploring all cancers are taking place: in the EU, Germany and the U.S.
• What are the key causes of breast cancer generally across the population and within certain cultural subgroups?
• In BRCA1/2-linked cancers, is there an additional impact of environmental factors, including diet, on the risk of developing
breast cancer?
• What is the interaction of genetic and environmental factors in breast cancer?
This area was determined to require investment (initiate), as no current or emerging breast cancer research programs
were identified in Canada.
Over the next five years, this area of research will require about $7.5M for two special RFAs. One will evaluate gene-
environment interactions in the etiology of breast cancer (with special consideration to polymorphisms). The other will
build on the findings of genome sequencing and environmental research to explore the environmental interactions and
biological implications of the genome sequencing. The requirement for the full $7.5M is conditional on the genome
sequencing project yielding important data that would justify further exploration.
1. Readiness to Initiate Research: The expertise exists to initiate research.

the health system as long-term studies will be needed to make any progress. In addition, a concerted effort by
many funding agencies will be needed to achieve results in this area.
3. Uniqueness to Breast Cancer: Research results will be a combination of insights, some of which will be unique to
breast cancer.
• Capacity training in emerging areas of expertise; e.g., bioinformatics;

• Building of a network of population health and genetics researchers to encourage joint grant submissions and
develop trainee capacity;
• Access to genome sequencing results.

CSO Category 3: Prevention
7. Interventions to study the influence of lifestyle and environmental factors on the risk
of developing breast cancer (linked to CSO code 3.1)
Specific factors continue to be identified as influencing the risk of developing breast cancer, particularly in some
subpopulations. Research in this priority area will aim to develop new population-based interventions that could be
introduced to reduce breast cancer incidence.
The most recent CCRA data reveals that less than 1% of total breast cancer research funding is dedicated to this field,
primarily through operating grant programs (75.8%) and personnel awards (24.2%).
CBCRA, in collaboration with CIHR, supported Translation Acceleration Grants (three projects funded for $6.6M) which
are exclusive to breast cancer. Ongoing and emerging initiatives for all cancers include the CIHR Team Grants on physical
activity, mobility and health and the CCS Prevention Initiative: Modifying risk factors and conditions in cancer prevention
($3M).
Internationally, several studies are investigating all cancers: in France, Finland and the U.K., which is undertaking a
national prevention research initiative for £12M (2008-2013) and the U.S. (NCI – two targeted competitions in alcohol
and nutrigenics).
• What population-based interventions can be introduced to reduce breast cancer incidence (including for high
risk women)?
• What is the role of primary care in terms of primary prevention?
This field was defined as needing more investment to encourage research (enable), since CIHR has a targeted initiative
(not specific to breast cancer) as does CCS (Prevention Initiative). In addition, the CBCRA/CIHR TAGS grants will end in
2009.
Researchers indicate that this area of research requires approximately $20M in investment over the next five years to
support primary prevention trials in collaboration with partners and international agencies. This research is unlikely to be
exclusive to breast cancer.
1. Readiness to Initiate Research: This area has a high degree of readiness to initiate research. However, a lengthy
lead time is likely necessary to put all of the required elements in place, including multidisciplinary teams with
behavioural scientists and epidemiologists. Longer-term funding mechanisms will also be required.

2. Timing of Impact: Research is likely to have a short- to longer-term impact (immediate to 5+ years) on patient
health and the health system.
3. Uniqueness to Breast Cancer: Behaviour change outcomes may be seen in the short to medium term but the
effects on breast cancer will take longer to become evident. Research results will not be unique to breast cancer.
One specific example for research system improvement is the development of a collaborative multicentre trial structure
for co-ordination of trials.
CSO Category 4: Early Detection, Diagnosis and Prognosis
8. Better approaches to early detection and diagnosis (linked to CSO code 4.1)
This research priority will focus on the development of new approaches to breast cancer screening and on the
discovery of new tools leading to more accurate diagnoses and to more personalized treatment of the disease.
The most recent CCRA data shows that about 6.7% of total breast cancer research funding is dedicated to this field,
primarily through operating grant programs (90.3%).
Several OICR projects are investigating all cancers, including the “Selective Agents” project in partnership with TFRI and ICGC.
Internationally, for breast cancer specifically, the PdCCRS in Australia receives about $10M of funding from Cancer
Australia and NBCF. In the U.S., Susan G. Komen for the Cure has funded work related to DCIS, experimental model
systems, identification and validation of biomarkers, and the development of environmental research methods. Many
international studies are taking place for all cancers in the EU, Sweden, France, the U.K., and the U.S., as well as through
an international cancer biomarker consortium.
• Who to treat, who to screen, with what, and with what benefits and costs?
• Are there more practical alternatives to RCTs?
• Can we distinguish between DCIS that will progress to aggressive invasive cancer and that which will remain in situ?
• Are there new screening tools that could be implemented (blood or serum related)?
• What type of screening can be targeted to high-risk populations more effectively?

This area was identified as needing more funding to encourage research (enable) given the current level of investment.
Researchers indicate that this area of research requires approximately $6M in investment using flexible funding
mechanisms such as small pilot studies but avoiding too many small grants to multidisciplinary teams. Partnering across
sectors and geographic regions will be key.
1. Readiness to Initiate Research: This field has a high degree of readiness to initiate because existing technologies
are ready for evaluation, considerable Canadian expertise exists in imaging and there is strong infrastructure
capacity in place from past CFI funding.
2. Timing of Impact: Research is likely to have a short- to medium-term impact (immediate to five years) on patient
health and the health system. Its impact will be influenced, however, by the attitudes and policies of Health
Canada and the FDA.
3. Uniqueness to Breast Cancer: Research results will be unique to breast cancer.
• Support for approval of new agents through the Health Canada regulatory process;
• Improving tissue banks through a co-ordinated, systematic approach to specimen collection/annotation which
would be required from all patients. Easier access for researchers to appropriate and annotated clinical materials;
• Capacity development for personnel with interdisciplinary expertise (e.g., imaging combined with biochemistry;
clinician scientists);
• Salary support for clinician scientists to have protected time for research;
• Support for new technologies.
9. Development and evaluation of new biomarkers (including biomarkers for diagnosis)

and the optimization of treatments for individual patients (linked to CSO code 4.2)
Research in this priority will lead to the discovery and validation of new biomarkers. New diagnostic biomarkers
will provide critical information for more accurate disease characterization. Predictive biomarkers will forecast patient
response to therapy and could lead to the development of new treatment targets.
The most recent CCRA data reveals that approximately 4.6% of total breast cancer research funding is dedicated to this
field, primarily through operating grant programs (85%).
CBCRA has a planned RFA in predictive oncology. Other ongoing and emerging initiatives include the TFRI Biomarker
initiative (which includes a breast cancer node) and the OICR initiative which addresses all cancers.

Australia and NBCF. Studies are underway for all cancers in the EU and in the U.K.
• Which parameters determine tumour response to therapy at the molecular/cellular level?

• What biomarkers are predictive of specific response to therapy?
• What degree of rigour is necessary to validate a biomarker?
• What are the specific pharmogenomic variables that would predict a patient’s response to therapy?
• How can a disease be characterized from imaging or other non-invasive tests; e.g., without biopsy?
• How can high-risk populations be defined more accurately?
• Are there particular molecular targets that are susceptible to interfere with or promote therapeutic agents?
• How can treatable targets associated with different subtypes of breast cancer be expanded?
This area was defined as needing new (evaluation of new biomarkers) as well as more (discovery of new biomarkers)
investment to encourage research (initiate and enable). New funding is required to enable Canadian breast cancer
researchers to validate targets or markers and initiate pre-clinical studies based on novel breast cancer targets.
Researchers indicate that this area of research requires approximately $12M in investment over the next five years
through a portfolio of different funding mechanisms. These options include companion studies to clinical trials
($100-500K per study with duration of one to three years); RFAs in specific areas (possibility of multi-institutional and
multidisciplinary projects at $5-10M per year); workshop support bringing experts from different disciplines together
to propose a larger-scale effort ($100K per workshop); retrospective studies “ready to act” on results of clinical
trials (included in RFA); and training support for methodology and statistical evaluation. Researchers emphasize the
importance of flexibility in the funding streams, avoiding too many small multidisciplinary teams, as well as the need to
link with pharma, Phase I clinical trials and other existing initiatives.
1. Readiness to Initiate Research: As the expertise is in place, this area has a high degree of readiness to initiate
research, although parts of the technology are still under development. Some concern has been expressed
regarding the recency of clinical trials with tissue samples, given that long-term outcomes are required to identify
prognostic and predictive markers.
2. Timing of Impact: Research is likely to have a medium-term impact (5+ years) on patient health and the health
system.
3. Uniqueness to Breast Cancer: Research results will not be unique to breast cancer.

• Increasing statistical and evaluation support staff with an understanding of biomarkers;

• Improving tissue banks by providing a co-ordinated, systematic approach to specimen collection/annotation
required from all patients; easier access for researchers to appropriate and annotated clinical materials; an
appropriate national patient consent process to facilitate tissue banking;
• Co-ordination and correlation with Phase 1 clinical trials;
• Linkage to existing cohort studies;
• Enhanced capability of breast cancer treatment/clinical system to participate in research; e.g., ability to process
and store samples, extract DNA, conduct microarray analysis and genomic assessment, pilot studies and bench
research;
• Development and acquisition of technology for tissue diagnostics.
10. Clinical setting/clinical trials to assess clinical sensitivity and specificity of new
biomarkers (linked to CSO code 4.3)

a. Subtypes of breast cancer
b. Predictive markers of response to therapy

Following the discovery of new biomarkers, clinical trials will be required to assess their use in a clinical setting,
particularly for some specific subtypes of breast cancer. The results of these trials will have an important impact on
the development of new personalized therapeutic strategies by providing predictive information on response to
therapy for specific groups of breast cancer patients.
The most recent CCRA data reveals that about 2.7% of total breast cancer research funding is dedicated to this field of
research, primarily through operating grant programs (91.3%).
No breast cancer specific funding has been identified. Ongoing and emerging initiatives for cancer as a whole include
the NCIC Clinical Trials Group (companion studies on clinical trials) and the OICR High Content Cancer Trials designed to
improve clinical trials, infrastructure and processes in Ontario.
Australia and NBCF. In the U.S., several multisectoral funders including Susan G. Komen for the Cure and the Fred
Hutchinson Cancer Research Center have launched a global breast health initiative. International studies investigating all
cancers are taking place in the EU, in the U.K. and the U.S., as well as through an International Cancer Screening Network.


• What are the best markers for decision making for therapy?
• How would one test the non-invasive procedures identified to characterize disease?
It was determined that this field needs new funding to encourage further research (initiate) given the limited number of
current projects specific to breast cancer that are testing new biomarkers.
Researchers indicate that this area of research requires approximately $15.5M over the next five years for two different
funding mechanisms: investigator-initiated operating grants ($1-2M per year) and companion studies to existing clinical
trials ($2-3M per year for clinical trials and $150K per year for three years for each study).
1. Readiness to Initiate Research: As the expertise is in place in specialized centres and current trials of the
predictive value of commercially available gene panels are already underway, this area has a high degree of
readiness to initiate research.
2. Timing of Impact: Research is likely to have a short- as well as a longer-term impact (immediate to 5+ years) on
patient health and the health system.
A specific area where improvements are required to the research system to enable success is in the qualitative and
quantitative evaluation of data. Requirements for improvement include:
• Better quantitative tools for assessment;

• Pharmogenomics expertise;
• Expertise in statistics;
• Serial collection of blood, plus fresh and frozen tissue for all subjects enrolled in clinical trials;
• Protected time for clinical technicians (e.g., in pathology).
CSO Category 5: Treatment
11. Discovery and development of new treatments for breast cancer

More specific and effective therapies are required for breast cancer patients. This research priority area will focus on the
development of better treatments, particularly for some specific subtypes of breast cancer.

area, primarily through operating grant programs (92.5%).
Current projects, specific to breast cancer, include CBCRA’s Predictive Oncology strategic initiative planned for launch in
2009 and the CBCRA/CIHR-funded Translation Acceleration Grants for $6.6M (2005-2009). Canadian initiatives such as
the Ontario Cancer Institute (OCI) Cancer Stem Cell Project, the TFRI pan-Canadian Biomarker Initiative in partnership
with CPAC and several OICR projects including the “Selective Agents” project in partnership with TFRI, the Immuno-and
Bio-therapies Project and ICGC are addressing all cancers.
Australia and NBCF. Many international studies are taking place to investigate all cancers: in the EU, France, Finland,
Germany, Australia, South Africa and the U.S.
• What is the functional meaning of breast cancer subtypes and its implication for treatment?
• What targeted therapies can be developed?
This area was defined as requiring further investment to encourage research (enable). CBCRA’s Predictive Oncology
initiative, to be launched in 2009, will provide $5M of funding. A portfolio of mechanisms is proposed for approximately
$12M of funding over the next five years. Examples include:
• Companion studies to clinical trials ($100-500K per study);

• Special operating grants envelopes ($100-500K per project);
• RFAs in specific areas ($5-10M per year);
• Strategic funding for workshops/larger-scale meetings to bring experts from different disciplines together to
propose larger-scale efforts ($1M for three to five years); retrospective studies, “ready to act” on the results of
clinical trials.
1. Readiness to Initiate Research: In terms of building on new understandings of disease identified in biology
studies, this area has a high degree of readiness to initiate. However, partnerships with industry are required
to bring laboratory discoveries to clinical trials; therefore, overall this area is assessed as being in a low state of
readiness.
2. Timing of Impact: Research is likely to have a long-term impact (10+ years) on patient health and the health
system.

• Enhancing the capability of labs to be clinical trials-oriented; e.g., improve their ability to process and store
samples, extract DNA, conduct microarray analysis and genomic assessments;
• Developing an appropriate national patient consent process to facilitate tissue banking;
• Developing and acquiring technology for tissue diagnostics;
• Developing rapid throughput models for testing large numbers of agents;
• Developing pre-clinical models for therapy evaluation;
• Working with industry to facilitate an appropriate level of involvement.
12. Clinical trials of new promising therapies (linked to CSO code 5.4)
Following the discovery of new promising therapies, clinical trials and related companion studies test these new
agents on breast cancer patients. Clinical testing and applications of new breast cancer therapies and the
assessment of side effects, toxicity and pharmacodynamics is a critical step in the implementation of these therapies.
The most recent CCRA data shows that about 1.4% of total breast cancer research funding is committed to this field,
primarily through operating grant programs (88.4%). Funding for the NCIC Clinical Trials Group is included in this breast
cancer breakdown. Examples include:
• A Phase II Study of a Second Generation Clustering Antisense Oligonucleotide (OGX-011) in combination with
Docetaxel in Advanced Breast Cancer;
• A Phase III Study of Regional Radiation Therapy in Early Breast Cancer.
Several CCS-funded clinical trials specific to breast cancer are currently underway. Canadian initiatives such as the TFRI
pan-Canadian Biomarker Initiative (in partnership with CPAC) and OICR project, including the Immuno- and Bio-therapies
Project and the High Content Cancer Trials, are investigating all cancers.
Australia and NBCF. Several international studies are taking place: in Finland, Germany and Australia.
• Do promising new agents have an impact on breast cancer (Phase I to Phase III)?
• What new therapies can be tailored to different subpopulations of breast cancer patients?

• Which novel clinical trial strategies will allow testing for all new promising therapies and combinations?
• How can new therapies be tested earlier on less-treated patients (Phase 0)?
Given the significant number of large clinical trials already in place, this area needs new and increased funding to
encourage (initiate and enable) the launch of companion studies. This research would focus on existing clinical trials as
well as investigator-initiated operating grants. Specifically, a portfolio of mechanisms is proposed for approximately $5M
over the next five years. Examples include:
• Companion studies to clinical trials ($100-500K per study);

• Host meetings assembling clinicians and scientists to hear about pending trials and explore opportunities ($250K
per year for two to three meetings);
• Investigator-led clinical trials (non-randomized), rapid trials (early stage Phase 0-Phase 2) ($150-500K per project);
• Funding for trials ($250K per trial for Phase II, several million for Phase III);
• Funding of core infrastructure (e.g., research nurses) for non-industry-sponsored trials ($500K per trial).
1. Readiness to Initiate Research: As the current infrastructure is in place, funded predominantly by the
pharmaceutical industry and CCS, this field has a high degree of readiness to initiate research.
2. Timing of Impact: Research is likely to have a short-, medium- and long-term impact (i.e., immediate and 10+
years) on patient health and the health system.
Specific areas where improvements are required to the research system to achieve success include:
• Capacity training in emerging areas of expertise, including functional imaging biopsies (e.g., PET, MRI) and trial
design;
• Increased links/partnerships with industry and co-operatives;
• Mechanisms to enable multiple partnerships with pharma in a single project;
• Administrative and research staff support for clinical trials.

CSO Category 6: Cancer Control, Survivorship, and Outcomes Research
13. Psychosocial and survivorship interventions (linked to CSO code 6.1)
Research in cancer survivorship covers the range of research domains from basic biomedical (e.g., to understand
the underlying mechanisms leading to late effects of treatment modalities); clinical (e.g., to test interventions
to ameliorate late effects; health service interventions to improve the quality of survivorship care; randomized
trials to improve the evidentiary basis for elements of follow-up care during survivorship); and population studies
(e.g., to understand the impact of public health interventions to improve lifestyle factors on the outcomes for
cancer survivors).
Research in quality of life could lead to the development of new interventions for improving the quality of life of
breast cancer patients across the course of the disease, and promoting psychological adjustment to the diagnosis
of breast cancer and to treatment effects.
area, primarily through operating grant programs (77.6%), personnel awards and related support grants (22.4%).
Current breast cancer projects were defined as follows: CBCRA Quality of Life/Survivorship for $2.1M (2006-2010) and
CBCRA/CBCF Special Research Competition on Psychosocial Aspects of Breast Cancer for $2.4M (2009-2014). CIHR
catalyst grants focused on biomedical and clinical approaches to improving quality of life for cancer survivors (one-year
grant, 2009-2010). The Sociobehavioural Cancer Research Network (SCRN), initiated by the Centre for Behavioural
Research and Program Evaluation (CBRPE) on behalf of CCS, conducts related research addressing all cancers.
Internationally, a Norwegian study on physical and mental health in breast cancer patients has been underway since
2007. This $2.9M (U.S. dollars) research has been sponsored by the Norwegian Cancer Society and Foreningen for
Brystkreftopererte. Many international studies are taking place for all cancers: in Australia, New Zealand, France, Finland,
Germany, the U.K. and the U.S.
• Which interventions best improve the quality of life of breast cancer patients during the course of the disease,
including survivors living after primary treatment?
• What is the influence of attitudes and beliefs on compliance to breast cancer treatment?
• How do we influence general health prevention behaviours?
• What are effective behavioural tests to lower lifestyle risk after cancer treatment?
This area was identified as needing more investment to encourage research (enable). Currently underway is the CBCRA/
CBCF Special Research Competition on Psychosocial Aspects of Breast Cancer for $2.4M (2009-2014). In addition, CPAC,

CCS and CIHR are planning other initiatives targeting this area. A range of research options is proposed such as pilot
grants, career awards, program project grants, team grants and operating grants.
A collective funding envelope of $18M is suggested to devote to all research defined in this category of cancer control,
survivorship and outcomes research.
1. Readiness to Initiate Research: This area has a medium/high degree of readiness to initiate research.
2. Timing of Impact: Due to the need to develop outcome measures and the challenge of translating findings into
policy and practice, research findings are likely to have a medium-term impact (5+ years) on patient health and
the health system.
3. Uniqueness to Breast Cancer: Research results may not be unique to breast cancer.
Specific areas where improvements are needed for the research system to achieve success include:
• Improving cancer centres by funding mechanisms to develop and test creative interventions including clinical
trials in the community;
• Enhancing laboratory equipment for exercise physiology and dietary testing in cancer centres and community venues;
• Providing funding for support staff for intervention trials and to gather data in community-based practice. Salary
support to allow clinician scientists to have protected research time;
• Developing administrative databases linked to population-based trials;
• Increasing research capacity, particularly for young investigators.
14. Analysis of the financial and health-care delivery issues facing breast cancer
patients across the cancer continuum (linked to CSO code 6.4)
This area of research examines quality of care, access to care (including timeliness and equity), and factors
associated with variations in quality and access. Studies examine the health system requirements to provide
optimum quality of care throughout the cancer continuum (from health system requirements to improved
screening, reduced wait times for diagnosis, and improved end-of-life care). This research also studies patients’
preferences and needs through the cancer continuum.
In addition, individuals affected by breast cancer and their family/caregivers face economic challenges. Research
in this area could focus on the financial implications of a breast cancer diagnosis; it could include an evaluation
of the long-term economic and employment implications for breast cancer patients and their families. The results
of this research could have an important impact on the development of new health services and care delivery policies.
The most recent CCRA data shows that only 1.8% of total breast cancer research funding is directed to this field,
primarily through operating grant programs (84%).

SCRN, initiated by CBRPE on behalf of CCS, conducts related research addressing all cancers. Other current and
emerging Canadian initiatives include the CIHR NET grants: Access to Quality Cancer Care for $10M (2007-2012); the
CCS Centre for Health Economics, Services, Policy and Ethics Research in Cancer Control (HESPE) and the OICR/CCO
Health Services Research Program. These studies analyze the benefits, risks and costs of existing and new interventions
to improve knowledge and policies for the delivery of cancer services.
Internationally, two Australian breast cancer projects were funded from 2005-2009 by Cancer Australia and NBCF. In
the U.S., Susan G. Komen for the Cure has funded community projects, community-academic partnership programs,
investigator-initiated research, promise grants and training in disparities research. Internationally, for all cancers, studies
are taking place in Australia, the U.K. and the U.S.
• Is care currently being delivered optimally to breast cancer patients?

• What are the long-term economic and employment implications for breast cancer patients?
• What are the economic and occupational implications of breast cancer on family/caregivers?
Although resources exist for research on all cancers in this area, no studies specifically for breast cancer are underway.
Therefore, more funding to encourage research is recommended (enable). The preferred funding mechanism is operating
grants.
A collective funding envelope of $18M is proposed to devote to all work defined in this category of cancer control,
1. Readiness to Initiate Research: This area has a high degree of readiness to initiate research.
2. Timing of Impact: Research findings will potentially affect patient health and the health system in the short term
(i.e., immediately).
Specific areas where improvements are required for the research system to enable success include providing capacity
training in emerging areas of expertise; e.g., for health-care economists.
15. Interventions to improve knowledge translation and disseminate best practices in

breast cancer across the cancer continuum (linked to CSO Code 6.5)
New initiatives in this area will aim to improve the application of research findings into policy and practice and
identify which KT interventions are most effective for breast cancer. An understanding of the barriers to and
supports for the successful application of research results to breast cancer is needed. Research will also identify

the most effective strategies to implement best practices in breast cancer care. This could include the development
of new communication approaches, tools and methods to facilitate, for example, communicating therapeutic
options to patients. This research could also have an important impact on breast cancer patients through significant
improvement in the translation of research findings into new policies.
The most recent CCRA data reveals that 0.4% of total breast cancer research funding is directed at this area of research.
This amount is split fairly evenly between personnel awards (48.2%) and operating grant programs (49%).
HESPE, CPAC’s Cancer Journey Action Group (through the program “Role of psychosocial education in delivering quality
care to cancer patients”) and OICR/CCO Knowledge Translation Research Network conduct related research dedicated
to all cancers.
Internationally, several studies investigating all cancers are being conducted in France and the U.S.
• What knowledge translation applications are effective within the breast cancer context?
• How can we improve the application of research findings into policy and practice across the breast cancer
continuum?
This area was identified as needing more investment to encourage research (enable). Currently underway is the CBCRA/
CBCF Special Research Competition on Psychosocial Aspects of Breast Cancer for $2.4M (2009-2014). In addition, CPAC,
CCS and CIHR are planning other initiatives targeting this area. Grants for multidisciplinary teams including policy-makers
and other stakeholders are the preferred funding mechanism.
A collective funding envelope of $18M is suggested to devote to all research defined in this category of cancer control,
1. Readiness to Initiate Research: This area may have a high degree of readiness to initiate research, depending on
the type of KT science required.
2. Timing of Impact: Research findings have the ability to influence patient health and the health system in the short
term (i.e., immediately).
Specific areas where improvements are required to the research system to facilitate success include mechanisms to
encourage greater involvement of partners, such as the community and policy-makers.

16. Developing mechanisms to link clinical trial data with administrative health
databases for studies on long-term outcomes and late effects (linked to CSO Code 6.9)
Linking data collected during clinical trials with administrative health databases enables long-term studies on
survivorship and quality of life issues related to breast cancer treatment. This form of linkage is potentially
powerful because data from clinical trials (where patients have been randomly assigned to treatments and where
the precise treatment regimens are known) may be linked with administrative health databases providing
information about long-term outcomes. For example, a clinical trial conducted in 1990, if linked with
administrative health databases running to 2005, could provide 15-year, patient-specific information on outcomes
compared to population controls. Research in this area will provide critical information for the development of
future therapeutic strategies and better understanding of late effects of treatments.
The most recent CCRA data shows that less than 0.10% of total breast cancer research funding is devoted to this area
primarily through operating grant programs (76%).
Canadian current and emerging programs include the HESPE, OICR/CCO Health Services Research Program and CPAC’s
initiative to improve capture of cancer disease stages in registries.
Internationally, several substantial studies are being conducted for all cancers. These include: the NCRI Informatics
Initiative, the National Cancer Research Network and National Cancer Intelligence Network in the U.K.; the Cancer
Biomedical Informatics Grid (caBIG), the NCI Community Networks and NCI Community Cancer Centers Program in the
U.S.; and the Seventh Research Framework Programme (FP7) in the EU designed to optimize the use of cancer registries
for 29 cancer research purposes.
• What are the long-term effects (e.g., cognitive functioning, fatigue, obesity) related to different treatment
regimens (chemotherapy, radiation therapy, surgery)?
Although resources exist in this area on all cancers, none is specific to breast cancer. Therefore, this area was defined as
needing research funding to encourage breast cancer studies (enable). The preferred support mechanisms are operating
grants combined with contract funding to support the development of position papers related to, for example, privacy and
logistical issues.
A collective funding envelope of $18M is suggested, directed to all research in this category of cancer control,
1. Readiness to Initiate Research: This area has a high degree of readiness to initiate research. However, privacy
policy requirements are a constraint.

2. Timing of Impact: The ability to have impact on patient health and the health system is assessed as medium to
long term (i.e., in the five to 10-year period).
Specific areas where improvements are needed for the research system to achieve success include improved access to
administrative health databases, improved cancer staging in cancer registries and the provision of capacity training in
emerging areas of expertise; e.g., programmers, statisticians and health informatics.
CSO Category 7: Scientific Model Systems
17. Developing new animal and cellular models to study response to therapeutics
and mimic human breast cancer development (linked to CSO code 7.1)
New animal and cellular models are required to study specific subtypes of breast cancer and their response to
treatment as well as breast cancer development and invasion.
The most recent CCRA data indicates that about 1.1% of total breast cancer research funding is directed to this field,
solely through operating grant programs (100%).
Two breast cancer projects are currently funded through CBCRA’s New Approaches to Metastatic Disease in Breast
Cancer, in partnership with CBCF and CRS, for $7M (2005-2010). An RFA competition dealing with bioinformatics and all
cancers is expected to be launched by CIHR in 2009.
Internationally, Susan G. Komen for the Cure has been funding (since 2007), research studying DCIS, experimental model
systems, identification and validation of biomarkers and the development of environmental research methods in breast
cancer. Several studies funded by NCI relating to all cancers include:
• Cancer Intervention and Surveillance Modeling Network (CISNET, Division of Cancer Control and Population
Sciences) for approx $2.7M per year over five years (2005-2011);
• Mouse Models of Human Cancers Consortium (MMHCC) for $18M over five years (2003-2008);
• The Integrative Cancer Biology Program (ICBP) for $14.9M (2004-2009).
• Which animal and tissue culture models best represent specific aspects of breast cancer?
• Using sophisticated model systems, can new mechanisms of breast cancer development be identified?
• How can animal models be used to determine whether specific subtypes of breast cancer are differentially
affected by therapeutics?

This area was recognized as needing new and additional funding to encourage research (initiate and enable) through
programs such as the creation of a breast cancer model network/consortium (similar to the mouse model consortium in
the U.S.), an RFA on model systems for breast cancer, and seed funding for research on other animal models. In addition,
IDEA or catalyst grants could support further research on the integration of several animal model systems and humans.
In recognition of the expense associated with mouse modelling a proposed $7.5M would be required over a five-year
period (approximately $1.5M per team per year). If single investigator operating grants were awarded they would
need to be larger than those currently available: approximately $250K per year per grant. Suggested seed funding is
approximately $200K per project.
1. Readiness to Initiate Research: As a result of technological advances, this area has a high degree of readiness
to initiate research. However, for optimal results, sustained support over time is required, as the impact of any
research is dependent on discoveries in other areas.
2. Timing of Impact: Research is likely to have more of a medium- to long-term impact (5+ years) on patient health
and the health system.
Specific areas where improvements are required to achieve success include:
• Capacity training in emerging areas of expertise; e.g.,

o Bioinformaticians and biostatisticians networks to aid in the design, analysis and development of new
animal models;
o Online training programs and workshops prior to online training;
o Model systems pathology (rodents and other animals).
• Funding for:
o Operating costs of animal facilities;
o Accessibility to repositories of mouse embryos;
o Inventory of investigators working on different animal models;
o Development of a consortium for collaboration and networking.

Prioritized Research Themes
NFWG developed a short list of overarching research themes with the potential to maintain Canada’s world-class status
or to extend it to new areas of significant promise where there is a good fit with the country’s existing strengths.
Five of these themes include many of the already identified 17 research priorities, with many of them spanning more
than one CSO category. The sixth, Knowledge Translation, is different and is presented as a required component within
all of the research themes. Several of these areas have already been identified by various stakeholders throughout the
consultation process undertaken by CBCRA, as described below.
A. Mechanisms of Cancer Development
Congenital and acquired genetic defects are responsible for cancer development. Prevention strategies would be
advanced with a better understanding of the genetic defects responsible for cancer development, their causes and
the mechanisms through which external factors promote genetic alterations. For example, one developing area of
research that shows promise is based on correlations between Body Mass Index and the risk of breast cancer. There are
also emerging discoveries linking metabolism to cancer (not specific to breast cancer). Essentially, this research theme
includes studies on cellular, biological, lifestyle factors; e.g., obesity or other risk factors and their influence on the risk of
developing breast cancer.
This is considered a high priority research area because of its potential impact in preventing breast cancer. However, it is
also one of the more high-risk priorities with respect to success in the near term.
Six of the 17 priorities identified by NFWG will focus on research questions in this theme. They are:
Priority # Priority Description

1 The genetic and epigenetic basis of breast cancer development
2 Deciphering the molecular pathways implicated in breast cancer initiation
4 The influence of lifestyle and environmental factors on the risk of developing breast cancer
5 The genetics and hormonal causes of breast cancer
Interventions to study the influence of lifestyle and environmental factors on the risk of developing
7
breast cancer
Developing new animal and cellular models to study response to therapeutics and mimic human
17
breast cancer development
Some aspects of this theme were also identified in the themes and priorities of three international consultation studies
and in the consultation of breast cancer survivors undertaken prior to the National Summit.54
B. Molecular Detection and Prediction
This research theme includes studies on early detection of breast cancer, including non-mammography-based tools.
It will also investigate more effective ways to distinguish between what is breast cancer and what is not, to reduce
overdiagnosis. It will also look at linking 3-D imaging to disease and microenvironment. Modern screening modalities,
while associated with a reduction in breast cancer mortality, still miss clinically significant disease in some populations.
Detection of smaller lesions is likely to be associated with detection of clinically irrelevant lesions. The use of more
sensitive detection strategies must be balanced against an understanding of which detected lesions progress to clinically
significant disease, and over what time period.
Advance reading materials for the National Summit are available at www.nationalframework.ca.
54

This is considered a high priority because of its feasibility and near-term impact on reducing mortality and morbidity from
breast cancer. It may provide a better understanding of disease and a link back to the etiology of the disease.
Three of the 17 research priorities identified by NFWG will address research questions in this theme. They are:

8 Better approaches to early detection and diagnosis
Development and evaluation of new biomarkers (including biomarkers for diagnosis) and the
9
optimization of treatments for individual patients
10 Clinical setting/clinical trials to assess clinical sensitivity and specificity of new biomarkers
This theme was not identified in the themes and priorities of the three international consultation studies. However, it was
mentioned in the consultation with breast cancer survivors undertaken prior to the National Summit.55
C. Personalized Medicine
Breast cancer describes a heterogeneous group of diseases with differing prognoses and therapeutic responsiveness.
Improved tumour classification and understanding of biologic behaviour is needed to define specific treatments that are
more effective and less toxic. Overtreatment should be avoided.
This research area includes systemic approaches to biomarker validation and gene targets, genomic screens, companion
studies with treatment links to identify biomarkers predictive of response to treatment, treatment of recurrent breast
cancer and decision-making tools for treatment of primary disease.
There is a general consensus that outcomes will be improved by optimizing and/or matching therapies to the precise
molecular characteristics of the cancer and by mapping therapy to the specific defects. This is because patients present
with many subtypes of disease and respond differently to therapy. Accounting for the patient’s personal tumour “life
history” is also expected to improve treatment efficacy.
This area cuts through several disciplines and could potentially result in significant research advances. For example, one
outcome could be a better use of health-care resources. Combined with earlier detection and diagnosis, studies could
also lead to reduced mortality/morbidity.
Nine of the 17 research priorities identified by NFWG will address research questions in this theme. They are:

2 Deciphering the molecular pathways implicated in breast cancer initiation
4 The influence of lifestyle and environmental factors on the risk of developing breast cancer
8 Better approaches to early detection and diagnosis
9
11 Discovery and development of new treatments for breast cancer
12 Clinical trials of new promising therapies
17
Ibid.
55

In addition, this research theme was also identified in the themes and priorities of three international consultation
studies, including the Top 10 Translational Priorities (St. Gallen), and in the consultation of breast cancer survivors
undertaken prior to the National Summit.56
D. Cancer Progression and Dissemination
Metastatic breast cancer ultimately kills patients with breast cancer. This research theme includes markers and predictors
of breast cancer progression/metastasis, understanding how to block metastatic pathways, the identification of which
lesions will progress to invasive cancer and prediction and prevention of breast cancer recurrence.
A recognized knowledge gap exists in metastatic disease research. For example, understanding which lesions progress to
life-threatening disease, and under what circumstances, will allow treatment to be planned accordingly. Prevention of breast
cancer spread would have a major impact on mortality, reduce the occurrence of relapse and increase the chances of cure.
Six of the 17 research priorities identified by NFWG will address research questions in this theme. They are:

9
12 Clinical trials of new promising therapies
17
In addition, this theme was identified in the themes and priorities of two of the three international consultation studies;
the Top 10 Translational Priorities (St. Gallen) and the U.K. Gap analysis. It was also recognized in the consultation of
breast cancer survivors undertaken prior to the National Summit.57
E. Psychosocial, Survivorship and Health Services
This research theme includes the psychosocial aspects of breast cancer, including interventions to improve the quality of
life of breast cancer patients throughout the course of the disease and health-care delivery to breast cancer patients. This
theme also encompasses biomedical and clinical approaches to access, survivorship and quality of life issues for breast
cancer patients (e.g., late effects).
The following five of the 17 research priorities identified by NFWG will address research questions in this theme.

9
Ibid.
56
Ibid.
57

Psychosocial and survivorship interventions
13
Analysis of the financial and health-care delivery issues facing breast cancer patients across the cancer
14
continuum
Developing mechanisms to link clinical trial data with administrative health databases for studies on
16
long-term outcomes and late effects
In addition, this theme was recognized in the themes and priorities of one of the three international consultation studies:
the U.K. Gap analysis, and in the consultation of breast cancer survivors undertaken prior to the National Summit.58
F. Transferring Knowledge into Practice

This cross-cutting theme reflects the intent of the National Framework to ensure that research makes a difference:
that evidence is moved into practice to the benefit of all Canadians. This theme establishes the expectation that in
all the work that is undertaken as part of the National Framework, ways are sought to ensure that the best questions
are formulated and funded, that what is known informs the development of further studies and that when a body of
knowledge emerges, it is used to inform, and possibly change, current practice and policy.
This research theme was not identified in the themes and priorities of the three international consultation studies, but
was recognized as a gap by breast cancer survivors during the consultation undertaken prior to the National Summit.59
Research System/Infrastructure Supports

NFWG members were asked to review the system gaps and infrastructure support or changes required to implement
each research theme. The advance reading materials for the National Summit and comments from that meeting formed
the basis for this review. Several gaps and infrastructure needs were recognized as cutting across some or all of the
research themes and can therefore be classified as system-wide issues.
These identified system-wide issues include:
• Tissue banks – the need for a co-ordinated systematic approach to specimen collection/annotation (fresh and
frozen tissues, blood, live stem cells, breast cancer subtypes); access to appropriate and annotated clinical
materials; and a national consenting process to facilitate tissue banking;
• Improved access to tissue microarrays and administrative health databases;
• Capacity training in emerging areas of expertise, especially interdisciplinary expertise, bioinformatics, and biostatistics;
• Infrastructure support – specifically administrative and research staff support, and protected time for clinician
scientists;
• Enhanced partnerships among different stakeholders – funders, industry, community members and policy-makers;
• Development of multidisciplinary, multisectoral and possibly international networks and consortia (tumour-
initiating cells, animal model systems, population health/genetics).
Ibid.
58
Ibid.
59

Discussion
Introduction
A new approach was taken in creating this National Framework: no comparable exercises have been undertaken in any
jurisdiction. Consensus was achieved on a broad set of priorities that span the breast cancer continuum. Several logistical
challenges were addressed: from compiling large amounts of background information into a succinct usable format, to
assembling a group of committed experts on a regular basis, to developing consensus within a limited time period on
specifics from a large amount of detailed information. In addition, the perspectives of all different disciplines needed to
be considered both individually and across the research spectrum.
From the outset, there was recognition of the need to retain the current foundational elements of breast cancer research.
For Canada to contribute world-class breast cancer research to a global society, it is important to fund the appropriate
balance of targeted and curiosity-driven (investigator-initiated) research and to provide sufficient capacity with a well-
resourced infrastructure. The challenge is that the right way to determine the optimum blend of investment is currently
unknown. Therefore, the research and funder communities need to continually ensure that the vitality of such critical core
elements as investigator-initiated grant competitions, clinical trials infrastructure, and platforms for innovation, including
biomarker development and molecular imaging, is maintained.
The National Framework provides a set of research priorities to inform more targeted research granting. This movement
toward targeted research granting is in keeping with the identified social trend of increased accountability of science to
society. It recognizes that knowledge has to be both scientifically and socially robust.60 Autonomous and self-directed
research is being balanced with more targeted research in areas defined typically by a multidisciplinary mix of scientists,
practitioners, policy-makers and other key stakeholders.
All of the breast cancer research priorities have been established in an inclusive manner using the Common Scientific
Outline and represent the full cancer continuum. This is in response to the expressed preferences of National Summit
participants for a balanced portfolio of research priorities. These priorities focus on outcomes, and are forward looking
while building on existing strengths. They are sensitive to the national and international research context and represent
scientific excellence. Each of the selected priorities, as well as the group as a whole, meets these criteria and – if funded
– will make a significant contribution to preventing or eradicating breast cancer, reducing its recurrence or, when it is not
curable, turning breast cancer from a killer into a chronic disease.
Using the National Framework

Given the rigour of the process used to define these priorities, funders may find it difficult to distinguish between them purely
on the basis of scientific merit. Funding choices will therefore need to be based on a combination of strategy and values. The
process of selecting priorities to fund will be guided by the mandate and direction established by the funder; for example, a
strategic plan to only fund prevention or research related to finding a cure.
In addition, NFWG applied such criteria as whether the findings would be unique to breast cancer, how long it would likely
take for research findings to have an impact on patient health and the health system, and how ready the research community
is to undertake the studies. The application of these screening criteria – or others, such as adopting a target group (e.g.,
young women) is not intended to characterize priorities as “better” or “more worthy”. Rather, the information is supplied to
help funders find the best fit, matching strategic direction and other preferences with the appropriate research priority. For
example, a funder who is particularly interested in improving quality of life and demonstrating short-term impact might select
studies that investigate interventions to improve the quality of life of those with breast cancer throughout the course of the
disease.
In the same vein, NFWG undertook some preliminary funding analyses to provide order-of-magnitude guidance to funders
over a five-year period (2010-2015). Funders should validate the financial numbers provided with the proposed mechanisms,
using a group of relevant experts as part of the due diligence process when developing a research request. Final funding
60
Nowotny H, et al (2001) Re-thinking Science Knowledge and the Public in an Age of Uncertainty – quoted in Alison Kitson and Mark
Bisby’s background paper: Speeding up the Spread, sponsored by the Alberta Heritage Foundation for Medical Research, June 2008.

amounts will then be reflective of the specific scope of the RFA as well as the funding available. NFWG believes that more
flexible and varied funding mechanisms should be used such as targeted RFAs and multidisciplinary team grants.
All of these discussions about research priorities took place in accordance with the CSO. NFWG then stepped outside
this framework and created six priority research themes, five of which include more than one of the identified priorities.
These themes represent a high degree of correlation with the preferences of survivors and participants at the National
Summit. Funders may find it advantageous to select a theme as the focus of their granting efforts if they want to enter
into a multi-year/multi-initiative commitment with the goal of making an impact in a particular area. For example, funders
interested in responding to survivor requests for less toxic and more personalized treatments for young women might be
interested in adopting the theme related to personalized medicine. Those who wish to adopt a strong patient-focused
approach might be interested in the Psychosocial, Survivorship and Health Services theme.
Guiding Principles
To foster the optimal return on research investment for funders and to keep moving the body of knowledge forward,
NFWG proposed a set of guiding principles for funding excellent high-impact research. Their advice to funders includes
the following:
• Avoid duplicating research already underway when setting up local studies. Be familiar with research results in
the area of interest and leverage existing research findings. Fund researchers to come together to help identify
and define high-leverage research questions;
• Explore possible linkages with global partners or funding collaboration with existing global cohorts;
• Embed knowledge translation approaches within the research whenever it makes sense;
• Integrate research and service delivery whenever possible, ensuring that the health-care system will support the
research; e.g., by having sufficient protected clinician scientist time and salary support for administrative staff in
clinical trials groups;
• Adopt a broad perspective across research disciplines, recognizing that multidisciplinary teams take time and
require funding to learn to work well together;
• Fund companion studies alongside clinical trials;
• Fund appropriate evaluation studies; e.g., the rapid assessment of a new technology.
Required System Changes

Research, by definition, occurs in a context. The Canadian research system boasts some admirable attributes: universal
health care has led to the adoption of some uniform treatment protocols; Canada’s multiculturalism provides a rich
research environment; and the country has acknowledged expertise in many areas including biomedical research, clinical
trials and health services.
However, to succeed in conducting the type of world-class research recognized in the National Framework, changes will
be required. These include improvements to the way that tissue bank specimens are collected and annotated, access to
clinical materials in tissue banks and the linkage of administrative health databases. Other needed improvements include
capacity development in high demand, complex areas like bioinformatics and biostatistics, an improved co-operative
environment across sectors and the development of more multidisciplinary networks and consortia. Infrastructure support
to provide clinician scientists with protected time and appropriate levels of administrative and research staff support is
also needed. Support and funding is required for the provision of an appropriate infrastructure and system to enable new
and novel research.

New Ways of Funding Research
In the final analysis, the cost of addressing the research priorities will exceed the current investment available to breast
cancer research, should the existing ways of funding research continue unchanged. Some trade-offs will be required,
especially in the short term with the current economic downturn and reduced levels of available research funds. Priorities
must therefore be clearly articulated and new collaborations sought. These new alliances could include non-traditional
partners such as industry. For Canada to maintain and improve its leadership status in breast cancer research, ways must
be found to sustain its core strengths and advance the identified priorities.

7. CALL TO ACTION
Overview
The priorities have been established. The challenging but rewarding work of taking action lies ahead. This chapter
discusses the benefits of collaborating and why an expectation has been created that breast cancer research funders
will be responsive and continue to support the foundational elements while adopting research priorities that fit their
strategic direction and values. It also outlines the commitment made by CBCRA to promote the adoption of the National
Framework and monitor progress. This section concludes by articulating some specific action items in the form of a call
to action directed to all members of the breast cancer research community.
Collaborating for Success
Funders of breast cancer research indicated before and during the Summit their interest in working together more
effectively. They recognize the benefit of jointly tackling projects that they could not accomplish alone. They want to
avoid duplicating the work of others. They are also interested in being part of a uniquely Canadian initiative that will lead
to better distribution of resources and optimal return on research investment. They want to associate themselves with
an exciting, ambitious agenda. They want a lead partner for cohesive joint efforts. And they want to use their funds in a
value-added way. They are looking for clear accountability, shared ownership and ongoing evaluation of research efforts.
They are also interested in gaining access to a high quality, national peer review process.61
Funders also understand that successful collaboration needs more clarity and definition of expectations, roles and
processes. For example, pooling funds to support a priority is different from dividing up a priority and asking individual
funders to support different elements. Both approaches could potentially succeed but they require different approaches,
different roles and offer different risks. Similarly, partnering with one or two others to fund individual breast cancer
research priorities differs from joining a larger group that creates and monitors the implementation of the National
Framework. Examples of the different types of collaborative partnerships are provided below.
Collaboration Options and Examples
CBCRA represents one kind of collaboration where the funding partners pool resources and jointly agree on which priorities
to fund. In addition, funding partners may choose to further support specific priorities that are closely aligned with their
individual goals.
A second example is the funding of investigator-initiated grants. A common peer review process is used to assess research
excellence. Different organizations fund the highest rated research proposals, starting at the top of the list, according to
agreed criteria such as a specific focus on breast cancer and the geographic location of the researcher. Resources are not
pooled, but efficiency is gained by using only one peer review process, requiring only one application submission. This allows
funders to choose the most appropriate way to use their investment.
Another scenario is different funding organizations focusing on parts of a larger research theme, but fairly autonomously. For
example, in the area of cancer survivorship, CPAC’s focus is on investigating and identifying current projects that address
survivorship issues with special attention to underserved populations. In contrast, CIHR is targeting biomedical issues. The
Centre for Behavioural Research and Program Evaluation, funded by CCS, targets the evaluation of quality of life/survivorship
programs and population health-level interventions.
A hypothetical third example involves three or four national organizations interested in funding capacity building combining
their efforts to obtain administrative efficiencies. They might identify critical gaps and necessary skills, and agree on their
preferred focus areas. They would then each set up their own career ladder and award structures based on the best fit with
their strategy and resources.
Advance reading materials for the Summit and Proceedings at www.nationalframework.ca.

61
Chapter 7: Call to Action 65.

CBCRA’s Commitment
Funding Priorities
The CBCRA Board has declared that in addition to funding high-impact research, the Alliance’s role over the next five
years (Phase IV) will be to enable the successful implementation of the National Framework. CBCRA will encourage
adoption of all the priorities and recommendations of the National Framework by all breast cancer research funders in
Canada. In pursuit of this goal, CBCRA will apply a range of strategies including hosting forums to maintain interaction
among funders and using its pooled research funds to attract other funders, working with them to find common interests
and developing new structures and funding mechanisms.
Monitoring Progress and Updating the National Framework
The National Framework document will be kept current. Emerging trends and activities in the cancer and health research
environments will be tracked. Trends in breast cancer research funding, annually and longer term, will be reported with
assistance from CCRA/CPAC. CBCRA will regularly host forums with groups of experts – possibly by priority or by theme
– to ensure that new knowledge is shared and introduced into the National Framework document. The implications
of all the data will be reviewed by a committee of national and international experts for its impact on the research
priorities. Updates will be published featuring progress reports and success stories. CBCRA will also publish and promote
opportunities to increase efficiencies in the funding, management and delivery of world-class breast cancer research.
Commitment to Collaborate
In short, CBCRA will champion the adoption of the National Framework. It will actively encourage those interested
to become part of a network, sharing learning experiences in pursuit of more effective funding practices. CBCRA will
proactively seek funding partners in priority areas – both for its own initiatives and for other funders; e.g., “brokering”
collaborations. Finally, CBCRA plans to host a national biennial forum to facilitate continued discussion, in a networking
environment and to celebrate achievements.
Turning Strategy into Action

CBCRA’s role as champion was endorsed at the National Summit. This strategic document is one of the first deliverables
in this role. Attendees expressed interest in working together in several areas. Many of these preferred areas have been
identified in the National Framework as national priorities, including metastasis, prevention, personalized medicine,
implementation of a cohort study and mining the cohort data. Other identified areas include addressing some of the
infrastructure issues such as tissue banks, and translating knowledge into policy and practice. The time is right for these
priorities to be collaboratively and strategically addressed. Therefore:
document and to work together to achieve the ultimate outcome: a world where no person need fear breast
cancer;
2. Breast cancer research funders across Canada are asked to adopt a set of guiding principles and to mobilize
support for both foundational research and the identified research priorities;
3. Policy and practice influencers are asked to apply existing research findings to policy and practice areas as they
relate to breast cancer, cancer and chronic disease, and to engage with researchers and academics to shape
future studies aligned with policy development;
66. Chapter 7: Call to Action

4. Industry (e.g., pharmaceutical companies,62 biotechnology companies, software developers, equipment
manufacturers) is encouraged to participate in new collaborative opportunities;
5. Provincial and hospital foundations are asked to allocate 10 per cent of their funds to these national priorities;
6. Donors are encouraged to familiarize themselves with the National Framework and to request that organizations
receiving their support embrace these priorities and recommendations.
62
Pharmaceutical companies involved in breast cancer research include: Abbott, Abraxis, Aegera Therapeutics, Amgen,
Angiochem, Antisoma Research, Ariad Pharmaceuticals, Array BioPharma, AstraZeneca, Aventis, AVEO Pharmaceuti-
cals, Bayer, Biomira Inc., Bionovo, BiPar Sciences, Boehringer Ingelheim Pharmaceuticals, Bristol Myers Squibb,
Celgene Corporation, Cell Therapeutics, Cephalon, Cytokinetics, Eisai Limited, Eli Lilly and Company, Fresenius Biotech
GmbH, Gem Pharmaceuticals, Genentech, Geron Corporation, GlaxoSmithKline, GPC Biotech, F. Hoffmann-La Roche,
ImClone Systems, Immutep S.A., Intarcia Therapeutics, Johnson & Johnson Pharmaceutical R&D, Ligand Pharmaceu-
ticals, Medarex, MediGene, MedImmune LLC, Merck Frosst, Novartis, Pfizer, Pharmacyclics, Pierre Fabre
Laboratories, Regeneron Pharmaceuticals, Sanofi Aventis, Sonus Pharmaceuticals.
Chapter 7: Call to Action 67.

68.
APPENDICES
Appendix A – CBCRA Board of Directors (2007-2009)
Leslie Cox (Chair), Avon Foundation for Women – Canada
Jacquelin Holzman (Vice-Chair), CBCN
Barbara Boyd, Director-at-Large
Dr. Phil Branton*, CIHR
Trish Bronsch*, CBCF
Dr. Pierre Chartrand*, CIHR
Dr. Elizabeth Eisenhauer, NCIC/CCS63
Diana Ermel, CBCN
Colleen Fleming, CBCF
Lois Harrison, CBCF
Carol Hiscock, CCS
Dr. Claire Holloway, RAC Chair
Jean Kammermayer*, Health Canada
Roberta Lacey, Avon Foundation for Women – Canada
Dr. Chris Lovato*, NCIC
Jackie Manthorne*, CBCN
Dr. Ivo Olivotto*, RAC Chair
Dr. Morag Park, CIHR
Dr. Cathy Popadiuk, Director-at-Large
Dawne Rennie, PHAC
Dianna Schreuer*, CBCN
Dr. Gurmit Singh, CBCF
Dr. Moira Stilwell*, CBCF
Mary Jane Thomson*, CBCF
Lianne Vardy*, PHAC
Dr. Barbara Whylie, CCS
Sharon Wood*, CBCF
Dr. Michael Wosnick, NCIC/CCS
Note: * Past members
As of February 1, 2009 NCIC was integrated into CCS and hence former NCIC members are also identified as representing CCS.
63
Appendix A 69.
Appendix B – Detailed Breakdown of Funding by CSO Code
As the aim of the National Framework is to establish actionable research priority areas, research investment within
each CSO category is shown by CSO code. The following table illustrates this breakdown and provides actual dollar
investment, the percentage contribution within the CSO category and the percentage contribution against total
investment. An analysis of this data provides the following insights:
• For breast cancer, two codes within the highest funded CSO category of Biology are the largest recipients of
funding, namely: 1.3 - Cancer initiation and 1.4 - Cancer progression and metastasis;
• The third highest funded code is 5.3 - Systemic therapies: discovery and development within the CSO category
Treatment;
• For All Cancers data, the highest funded CSO category is Biology. However, the highest proportion of funding is
code 1.1 - Normal functioning, followed by Systemic therapies in the CSO category Treatment;
• Across all CSO categories, breast cancer receives minimal funding for resources and infrastructure.
Table 5: Distribution of 2007 Breast Cancer Research Investment by CSO Code64
Breast Cancer65 All Cancers

CSO
CSO Code
Category 2007 % Total % Category 2007 % Total % Category
Investment Investment Investment Investment Investment Investment
Total $19,142,626 40.9 $179,195,863 44.5
1.1 - Normal functioning $1,481,481 3.2 7.7 $64,458,426 16.02 35.97

1.2 - Cancer initiation:
$1,319,944 2.8 6.9 $9,373,089 2.33 5.23
alterations in chromosomes
1.3 - Cancer initiation:
1 - Biology
oncogenes and tumour $7,193,662 15.4 37.6 $47,205,335 11.73 26.34
suppressor genes
1.4 - Cancer progression and
$9,129,678 19.5 47.7 $25,790,992 6.41 14.39
metastasis
1.5 - Resources and
$17,861 0.04 0.09 $32,368,021 8.04 18.06
infrastructure
Total $4,739,049 10.1 $42,535,387 10.6
2.1 - Exogenous factors in the

$967,556 2.1 20.4 $11,322,190 2.81 26.62
origin and cause of cancer
2.2 - Endogenous factors in
$2,999,970 6.4 63.3 $21,111,258 5.25 49.63
the origin and cause of cancer
2-
Etiology 2.3 - Interactions of
genes and/or genetic
polymorphisms with $714,648 1.5 15.1 $2,590,079 0.64 6.09
exogenous and/or
endogenous factors
2.4 - Resources and
$56,875 0.1 1.2 $7,511,859 1.87 17.66
infrastructure
64
Canadian Cancer Research Alliance: Cancer Research Investment in Canada, 2007: The Canadian Cancer Research Alliance’s Survey of
Government and Voluntary Sector Investment in Cancer Research in 2007. Toronto: CCRA, 2009.
65
Only projects weighted at 100% breast cancer are included in the breast cancer breakdown.
70. Appendix B
CSO
CSO Code
Total $623,015 1.3 $7,049,498 1.8
3.1 - Interventions to prevent

cancer: personal behaviours $247,994 0.5 39.8 $3,696,682 0.92 52.44
that affect cancer risk
3.2 - Nutritional science in
$21,073 0.04 3.4 $622,856 0.15 8.84
cancer prevention
3-
Prevention 3.3 - Chemoprevention $287,325 0.6 46.1 $567,852 0.14 8.06
3.4 - Vaccines $51,678 0.1 8.3 $362,053 0.09 5.14
3.5 - Complementary and
alternative prevention $0 0 0 $357,125 0.09 5.07
approaches
3.6 - Resources and
$14,945 0.03 2.4 $1,442,931 0.36 20.5
infrastructure
Total $7,244,530 15.5 $43,382,278 10.8
4.1 - Technology
development and/or marker $3,142,189 6.7 43.4 $18,457,387 4.59 42.55
discovery
4 - Early 4.2 - Technology and/
Detection, or marker evaluation with
Diagnosis $2,126,493 4.5 29.4 $7,918,762 1.97 18.25
respect to fundamental
and parameters of method
Prognosis
4.3 - Technology and/or
marker testing in a clinical $1,282,407 2.7 17.7 $5,285,889 1.31 12.18
setting
4.4 - Resources and
$693,441 1.5 9.6 $11,720,239 2.91 27.02
infrastructure
Total $9,644,799 20.6 $90,402,915 22.5
5.1 - Localized therapies –

$460,893 1.0 4.8 $6,024,885 1.50 6.66
discovery and development
5.2 - Localized therapies –
$1,565,417 3.3 16.2 $3,662,906 0.91 4.05
clinical applications
5.3 - Systemic therapies –
$6,075,331 13.0 63.0 $50,134,377 12.46 55.46
discovery and development
5- 5.4 - Systemic therapies –
$661,406 1.4 6.9 $7,378,062 1.83 8.16
Treatment clinical applications
5.5 - Combinations of
localized and systemic $211,436 0.5 2.2 $681,517 0.17 0.75
therapies
5.6 - Complementary
and alternative treatment $13,750 0.03 0.1 $236,248 0.06 0.26
approaches
5.7 - Resources and
$656,566 1.4 6.8 $22,284,919 5.54 24.65
infrastructure
continued...
Appendix B 71.
CSO
CSO Code
Total $4,872,261 10.4 $36,622,595 9.1
6.1 - Patient care and

$2,115,905 4.5 43.4 $10,296,158 2.56 28.11
survivorship issues
6.2 - Surveillance $744,380 1.6 15.3 $2,311,612 0.57 6.31
6.3 - Behaviour $777,285 1.7 16.0 $5,212,877 1.30 14.23
6.4 - Cost analyses and

$848,554 1.8 17.4 $5,824,913 1.45 15.91
6 - Cancer health-care delivery
Control, 6.5 - Education and
Survivorship $200,331 0.4 4.1 $2,378,856 0.59 6.50
communication
and
Outcomes 6.6 - End-of-life care $11,580 0.02 0.2 $3,620,621 0.90 9.89
6.7 - Ethics and confidentiality

$10,313 0.02 0.2 $162,155 0.04 0.44
in cancer research
6.8 - Complementary and
alternative approaches for
$116,745 0.2 2.4 $476,828 0.12 1.30
supportive care of patients
and survivors
6.9 - Resources and
$47,168 0.1 1.0 $6,338,575 1.58 17.31
infrastructure
Total $508,654 1.1 $3,259,655 0.8
7.1 - Development and

characterization of model $508,654 1.1 100.0 $2,817,029 0.70 86.42
7- systems
Scientific 7.2 - Applications of model
Model $0 $0
systems
Systems
7.3 - Resources and
$0 $442,626 0.11 13.58
infrastructure
TOTAL $46,774,937 $402,448,190
72. Appendix B
73.
74.
Appendix C – Definition of Key Terms
Angiogenesis:
Angiogenesis is a physiological process involving the growth of new blood vessels from pre-
existing vessels. It is a normal and vital process in growth and development; however, it is
also a fundamental step in the transition of tumours from a dormant state to a malignant one.
Annotated clinical materials:

Clinical specimens stored in tissue banks are associated with clinical information on the
individuals who donated them; e.g., demographics of the donor, pathology report, treatment
details. When such information is available and linked to the specimen in a database, the
clinical material is considered to be annotated.
Bioinformatics:
Computational approaches to analyze, manage, and store biological data. Bioinformatics
involves the analysis of biological information, using computers and statistical techniques,
the science of developing and using computer databases and algorithms to accelerate and
improve biological research. Bioinformatics is used to analyze genomes and proteomes
and for three-dimensional modelling of biomolecules and biologic systems. Training in
informatics requires a background in molecular biology and computer science, including
database design and analytical and statistical approaches.
Biomarker:
A specific biochemical or other measurable parameter in the body with a feature that makes
it useful for measuring the progress of disease or the effects of treatment.
Biomedical:
Relating to the activities and applications of science to clinical medicine.
Biostatistics:
The application of statistical science to biology.
Career awards (also known as salary awards):

Competitive awards that provide protected time for research on a long- or short-term
basis to outstanding individuals who have demonstrated high levels of productivity and
research accomplishments. Research chairs, establishment grants and grants designed to
facilitate the recruitment of outstanding researchers are also included under this funding
mechanism.
CBCF:
Canadian Breast Cancer Foundation.
CBCN:
Canadian Breast Cancer Network.
CBRPE:
Centre for Behavioural Research and Policy Evaluation.
CCO:
Cancer Care Ontario.
CCS:
Canadian Cancer Society.
CCSRI:
Canadian Cancer Society Research Institute (formerly National Cancer Institute of Canada).
Appendix C 75.
CFI funding:
The Canada Foundation for Innovation is an independent corporation created by the
Government of Canada to fund research infrastructure. CFI normally funds up to 40% of
a project’s infrastructure costs in partnership with eligible institutions. Funding partners
from the public, private, and voluntary sectors provide the rest of the funding.
Chemoprevention:
The use of drugs or other agents to reduce the chances of developing cancer or the
return of the disease.
CIHR:
Canadian Institutes of Health Research.
CIHR ICR:
Canadian Institutes of Health Research Institute for Cancer Research.
Cohort study:
A cohort (group of individuals who share a common characteristic) study is a form of
longitudinal study used in medicine and the social sciences. It is often used to study an
association between cause and disease.
Common Scientific Outline (CSO):

A classification system based on seven broad areas of scientific interest in cancer
research. This was developed by the International Cancer Research Portfolio, a joint
initiative of International Cancer Research Partners. www.cancerportfolio.org/cso.isp.
Companion study:
A translational study based on validating targets in another model (e.g., preclinical) or
using tumour biopsies for other types of research.
CPAC:
Canadian Partnership Against Cancer.
CRS:
The Cancer Research Society.
CSO classification system:

See “Common Scientific Outline”.
DCIS:
Ductal carcinoma in situ. A very early form of breast cancer in the lining of the breast
ducts, also known as intraductal breast cancer or Stage 0 breast cancer.
Epidemiology:
The study of the patterns, causes, and control of disease in groups of people. When
applied to cancer, it may involve looking at how many people have cancer or develop
specific types of cancer. It also investigates which factors, such as genetics or personal
behaviour, play a role in the development of cancer.
Epigenetic changes:
Any changes in an organism caused by alterations in the action of genes are called
epigenetic changes. Epigenetic transformation refers to those processes that cause
normal cells to become tumour cells without the occurrence of any mutations.
Equipment/infrastructure grants:
Grants that cover in part or in full the costs of construction or major renovation of
research facilities, and/or the purchase, housing and installation of equipment, scientific
collections, computer software, information databases, and communication linkages used
primarily for conducting research.
76. Appendix C
Etiology:
The cause of disease or disorder.
Exogenous:
Originating from outside a system.
FDA:
The U.S. Food and Drug Administration is the federal agency responsible for ensuring
that foods are safe and nutritious. The FDA also regulates human and veterinary drugs,
biological products and medical devices.
Functional imaging:
A method of detection or measuring physiological changes within an organ or tissue by
using medical images.
Gene panels:
A group of genes relevant to a biological process (e.g., response to treatment) usually
identified through genomic profiling.
Genome sequencing:
The process of determining the order of DNA nucleotides or bases in a genome.
Genomic assessment:
Determination of genomic changes associated with a disease or a treatment.
Health informatics:
The interface of information science, computer science and health care.
HESPE:
Centre for Health Economics, Services, Policy and Ethics Research in Cancer Control.
High throughput technologies:

Robotic devices used to conduct thousands of experiments simultaneously.
ICGC:
International Cancer Genome Consortium.
IDEA grants:
A grant program which supports innovative, new research ideas that are speculative, but
have the potential for advancing scientific knowledge.
Investigator-initiated grant:
A type of research grant in which Principal Investigators (PIs) propose investigations of
curiosity-driven hypotheses.
Knowledge translation (KT):

A dynamic and iterative process that includes synthesis, dissemination, exchange and
ethically sound application of knowledge to improve the health of Canadians, provide more
effective health services and products and strengthen the health-care system.66
Metastatic breast cancer:

The spread of cancer from the breast to another part of the body. Cancer cells can break
away from primary tumours and travel through the bloodstream or lymphatic system to the
lymph nodes, brain, lungs, bones, liver or other organs.
Microarray:
A multiplex technology used in biology and medicine that uses an arrayed series of
thousands of microscopic spots of DNA sequences.
66
CIHR definition of KT may be found on CIHR’s website, at www.cihr-irsc.gc.ca/e/39033.html.
Appendix C 77.
Molecular imaging:
A discipline that combines molecular biology and in vivo imaging to visualize molecular
processes in living organisms without perturbing them. Molecular imaging often uses
biomarkers to obtain images from specific molecular pathways or other areas.
NBCF:
National Breast Cancer Foundation.
NCI:
National Cancer Institute.
NCIC:
National Cancer Institute of Canada; now known as the Canadian Cancer Society Research
Institute (CCSRI).
NCRI:
National Cancer Research Institute.
OICR:
Ontario Institute for Cancer Research.
Oligometastases:
Metastases that are limited in number and location and usually found in the brain, lung,
liver and bone.
Operating grants:
Grants that support all the direct costs involved in conducting specific research projects.
Operating grants typically cover salaries for laboratory staff and research assistants/
associates/trainees, costs of research equipment and supplies, and other specific
research-related expenses. Multicomponent projects (program projects), feasibility grants,
proof-of-principle grants, regional development grants, innovation grants and knowledge
translation grants are all included in this category.
PdCCRS:
Priority-driven Collaborative Cancer Research Scheme. A collaboration between Cancer
Australia and the National Breast Cancer Foundation (NBCF).
PHAC:
Public Health Agency of Canada.
Pharmogenomics (or pharmacogenomics):

The study of the influence of genetic variation on drug response.
PI:
Principal Investigator.
Pillar research:
CIHR categorizes health research into four broad pillars: Biomedical; Clinical; Health
services; and Social, cultural, environmental and population health. Many topics are
cross-cutting; that is, the same topic may be researched across all four pillars.
Polymorphisms:
Multiple versions (alleles) of a gene within a population, usually expressing different
phenotypes (observable characteristics).
RAC:
Research Advisory Committee of the Canadian Breast Cancer Research Alliance.
78. Appendix C
Randomized controlled trial (RCT):
A study in which individuals are randomly chosen to receive one of several clinical
interventions.
Related support grants:

Competitive grants that support travel, workshops/symposia and researcher time for
proposal development/letters of intent. These grants involve small sums of money.
Research system:
The funding mechanisms, infrastructure requirements, key processes (such as planning and
surveillance) and human resources needed to support a world-class research enterprise.
RFA:
Request for Applications. A formal invitation for grant or co-operative agreement
applications. The applications are for specific objectives in well-defined scientific areas.
Salary awards:
See “Career awards”.
SCRN:
Sociobehavourial Cancer Research Network.
Subtypes of breast cancer:

Breast cancer can be subdivided into several molecular subtypes; e.g., luminal A, luminal
B, basal-like or HER2/neu-positive.
Systems biology:
A biology-based, interdisciplinary study field that focuses on the systematic investigation
of complex interactions in biological systems, viewing the organisms as an integrated and
interacting network of genes, proteins and biochemical reactions.
Targeted research:
A type of research grant in which the research topic is established by the funding agency
and PIs must submit proposals within prescribed parameters.
TFRI:
Terry Fox Research Institute.
Tissue banks:
A collection of biomedical specimens (blood, tissue, urine, etc.) stored under cryogenic
conditions, donated by volunteer patients or healthy individuals and often used for
biomedical research.
Tissue microarrays:
Paraffin blocks in which up to 1,000 separate tissue cores are assembled in array fashion
to allow multiplex histological analysis.
Translation Acceleration Grants (TAGS):

A targeted, group grant competition open to multidisciplinary teams of three or more
independent researchers who are recognized experts in the field of breast cancer, to
accelerate the translation of basic breast cancer research findings into practice. (A
CBCRA/CIHR-funded program).
Appendix C 79.
80.

National Framework

Uploaded by

Document Information

Original Description:

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

National Framework

Uploaded by

Copyright:

Available Formats

A ROADMAP FOR RESEARCH

FIRST EDITION – DECEMBER 2009

© Canadian Breast Cancer Research Alliance, 2009 Contact:

Listing of Working Groups 5

3. Rationale for the National Framework 17

4. Setting the Context 19

5. Approach and Methodology 23

6. Identifying the Research Priorities 33

LISTING OF WORKING GROUPS

Part One: National Summit Working Group Members

Dr. Morag Park (Co-Chair) Dr. Claire Holloway

6. Chapter 1: Executive Summary

The National Framework represents a new paradigm

The National Framework identifies areas for high-impact research

Six overarching research themes were identified:

A. Mechanisms of Cancer Development

B. Molecular Detection and Prediction

D. Cancer Progression and Dissemination

E. Psychosocial, Survivorship and Health Services

F. Transferring Knowledge into Practice.

Chapter 1: Executive Summary 7.

CSO Category Research Priority

1. GENETICS – The genetic and epigenetic basis of breast cancer development

8. DETECTION – Better approaches to early detection and diagnosis

13. SURVIVORSHIP AND QUALITY OF LIFE INTERVENTIONS – Psychosocial and survivorship

The National Framework requires a realignment of existing and

8. Chapter 1: Executive Summary

The National Framework includes a Call to Action

A National Framework for Breast Cancer Research

CBCRA has facilitated the development of the National Framework,

The National Framework represents a new paradigm in

Features defining this new paradigm include:

10. Chapter 2: Summary

The six research themes are:

Includes research on cellular, biological, lifestyle factors; e.g., obesity or other

Chapter 2: Summary 11.

Research in cancer survivorship covers the range of research domains from

Chapter 2: Summary 13.

14. Chapter 2: Summary

The National Framework requires a realignment of existing and

The National Framework includes a Call to Action16

Chapter 2: Summary 15.

4. Industry (e.g., pharmaceutical companies, biotechnology companies, software developers, equipment

16. Chapter 2: Summary

Setting the Stage

Defining the National Framework

Chapter 3: Rationale for the National Framework 17.

Outline of this Document

This entire document is available online at www.nationalframework.ca.

18. Chapter 3: Rationale for the National Framework

Number of New Cases 22,700

Incidence Rates 102 per 100,000

Per cent of All Cancers in Females 27.8%

Incidence Rank in Females 1*

Number of Deaths 5,400

Mortality Rate 22 per 100,000

* Excluding non-melanoma skin cancer

Chapter 4: Setting the Context 19.

Figure 1: Cancer Research Investment by Cancer Site

BRAIN $15.1M BREAST $54.6M

OTHER SITES $59.2M

TOTAL INVESTMENT - $402,448,190 FROM 2007 CCRA DATA

20. Chapter 4: Setting the Context