This #TalkClinicalTrials blog highlights a powerful patient-led initiative from Rethink Breast Cancer calling for greater inclusion of people living with metastatic breast cancer (MBC) in clinical trials. The Statement on Metastatic Breast Cancer + Clinical Trials urges the research community to re-examine long-standing practices that routinely exclude MBC patients—despite the critical role trials play in offering hope, improving quality of life, and advancing treatment.
Written based on interviews with MJ DeCoteau, Founder + Executive Director, Rethink Breast Cancer, and Margaret Loniewska, MBC community member, Rethink Key Collaborator, and member of Rethink’s MBC Advisors Group.
Too often, people living with metastatic breast cancer (MBC) are excluded from clinical trials—even when those trials don’t necessarily require that exclusion. For many patients, this means losing access to the very research that could improve their quality of life and, potentially, their prognosis.
To help shift this reality, Rethink Breast Cancer has released the Statement on Metastatic Breast Cancer + Clinical Trials—a patient-led call to action for the research community to rethink how MBC patients are included in trial design, access, and execution.
Who is Rethink Breast Cancer?
Rethink Breast Cancer is a Canadian charity committed to challenging the status quo and creating change in breast cancer care. For nearly 25 years, they’ve been building a community that empowers and supports women diagnosed at a younger age, people living with MBC, and those often marginalized due to other social determinants of health within the cancer care system.
Rethink’s work is grounded in evidence, shaped by real-world experiences, and guided by clinicians and researchers who understand that advocacy and science are not mutually exclusive. Through education, community building, and system-level advocacy, Rethink aims to ensure that breast cancer outcomes improve and that no one faces breast cancer feeling unseen or unheard
Why the Statement was Created
The Statement on Metastatic Breast Cancer + Clinical Trials is rooted in lived experience. It was sparked during an MBC Advisory Committee meeting, where a member shared her frustration after being excluded from a breast cancer and exercise trial—not because of her abilities or health status, but solely because of her MBC diagnosis.
Stories like hers are all too common. Many MBC patients actively seek out opportunities to participate in research, only to discover that their diagnosis disqualifies them—even when participation could be safe and meaningful. With new treatments extending life expectancy, many people with MBC are living well and want to contribute to the future of cancer care.
So, Rethink and their group of MBC Advisors asked: What if research better reflected the reality of living with MBC?
That question led to the development of a patient-centred position paper created by MBC community members and reviewed by physicians on Rethink’s Medical Advisory Board. It offers a blueprint for more inclusive research, tackling key issues like:
- Inclusion in trial design: Engaging trained MBC patients early in the process.
- Relevance: Designing trials that align with the current MBC treatment landscape.
- Accessibility: Using plain language and removing unnecessary barriers to participation.
- Representation: Ensuring diversity in age, race, gender, and lived experience.
- Recruitment: Putting patient priorities at the center of trial outreach and engagement.
- Clinical trial access: Considering people with MBC as individuals with a spectrum of needs and abilities.
What Rethink Hopes to Achieve
Rethink hopes that the Statement inspires researchers and physician-scientists to think differently when designing trials and studies. They hope to impact the decisions that are made on inclusion criteria for clinical trials and quality of life projects. This could mean including people living with MBC when it’s clinically safe, designing research that is more patient-centric or even inspiring more research in MBC.
They would also like patients to read the Statement and become empowered to question exclusion criteria further when they see MBC patients being excluded from research.
A Message to the Clinical Trials Community
To those working in research, clinical trials represent hope for people living with MBC to improve both prognosis and quality of life. When that door is closed simply because of diagnosis—not because of risk or medical necessity—it sends the message that patients have been left behind.
The message is simple: Include us. Hear us. Partner with us—from start to finish.
Patient voices and the insights from patient groups like Rethink are not nice-to-have. They are essential to building more equitable, responsive, and effective research systems.
Looking Ahead
The Statement on Metastatic Breast Cancer + Clinical Trials is one step toward a more patient-centred research culture—one that doesn’t treat people living with MBC as too complex or too fragile to be part of the process.
Rethink believes that engaging patient advocates early in research leads to better-designed studies, stronger participation, and more meaningful outcomes. It also ensures that the system evolves in ways that reflect the realities of those it aims to serve. Patients and caregivers can have a lot of impact on our overall health care system, particularly in cancer care.
As they look to the future, they also call for the collection of MBC recurrence data in Canada to inform smarter trial design and policy decisions. Better data, paired with inclusive practices, can help shape a research landscape where no one is left behind.
You can read the full Statement on Metastatic Breast Cancer + Clinical Trials here.