Breast Cancer Clinical Trials: A Need for Diversity

When people hear “breast cancer clinical trial,” they often picture white-coated scientists, complex lab charts, and maybe a very serious montage from a medical drama.
What most of us don’t picture is the person in the exam room: a Black woman in her 40s, a Latina grandmother, an Asian American college student, or a Native woman who has to drive three hours just to see an oncologist.

That’s a problem because the lifesaving treatments we use today are built on yesterday’s clinical trials. And if the people in those trials don’t reflect the people who will actually use the drugs in real life, we get blind spots in safety, dosing, and effectiveness.

In breast cancer, those blind spots are not just theoretical. They show up as real differences in survival, side effects, and access to new therapies, especially for Black, Hispanic/Latino, Indigenous, and other historically marginalized communities.
Yet racial and ethnic minorities still make up less than about 10–15% of participants in breast cancer clinical trials overall, despite making up a much larger share of patients.

Why Diversity in Breast Cancer Clinical Trials Matters

Breast cancer is not one single disease. It comes in many biological subtypes, behaves differently from person to person, and is shaped by genetics, hormones, environment, and social conditions. Race and ethnicity, which reflect complex mixes of ancestry and lived experience, can influence:

• How fast a tumor grows or spreads
• How a person metabolizes medications
• Which side effects are more likely or more serious
• Who gets diagnosed early versus late

Research has shown that Black and Hispanic/Latino patients are considerably underrepresented in breast cancer trials, even though Black patients account for around 12% of new breast cancer cases in the United States but only about 3% of participants in many breast cancer drug trials.
Other analyses of breast cancer trials leading to FDA approval found that roughly three-quarters of participants were white, with only about 2% Black and under 4% Hispanic.

That imbalance matters. If most of the data come from white women, we may miss:

• Differences in how certain drugs work in people with different ancestries
• Unique side-effect patterns or toxicity risks in specific groups
• Opportunities to tailor treatment or prevention strategies for communities with higher mortality

In simple terms: diversity in clinical trials is not about optics or “checking a box.” It’s about making sure that when we say a treatment is safe and effective, we mean it for everyone who might need it.

The Current State of Diversity in Breast Cancer Trials

The good news: there has been some progress. Analyses of National Cancer Institute (NCI)–sponsored cancer trials show that participation by Hispanic/Latino and Asian/Pacific Islander patients has increased over the last two decades, and overall minority enrollment is slowly rising.

The not-so-good news: the numbers still lag far behind the makeup of the U.S. population and the actual breast cancer burden. Many breast cancer clinical trials still enroll a heavily white, more affluent group of participants, leaving the very communities with the worst outcomes underrepresented.

For example:

• Minority patients often represent under 10–15% of breast cancer trial participants overall.
• Black patients are disproportionately likely to develop aggressive subtypes, such as triple-negative breast cancer, yet are still under-enrolled in many studies of cutting-edge therapies targeting these tumors.
• Trials frequently happen at large academic centers that are far from rural areas or neighborhoods with fewer resources, where many patients of color receive care.

So, yes, we’re moving in the right direction just not nearly fast enough, and not evenly across all types of trials.

It’s Not About Willingness: Barriers Run Deeper

One of the most persistent myths is that patients from underrepresented communities are simply “less willing” to join clinical trials.
But several studies have found that when breast cancer patients of different races and ethnicities are offered a trial and have enough information, their willingness to participate is similar.

So what’s really going on? Researchers often group the barriers into three big buckets:
awareness, opportunity, and acceptance.
Let’s translate that into real-life issues.

1. Awareness: “I didn’t even know a trial was an option.”

Many patients regardless of race are never told that a clinical trial might be right for them. But this gap tends to be even wider in under-resourced communities and community oncology practices.

Some reasons:

• Clinicians may not be aware of open trials at other centers.
• Trial descriptions can be full of jargon, making it hard to understand who is eligible.
• Patients may assume that “trials are for people with no options left,” rather than a valid choice at multiple stages of treatment.

2. Opportunity: “I can’t get there, I can’t get off work, and I can’t afford it.”

Even when a trial exists, access can be a logistical marathon. Practical barriers reported by patients include lack of transportation, lack of health insurance or underinsurance, out-of-pocket costs, and the time demands of frequent visits.

Think about a person who:

• Works an hourly job with no paid time off
• Relies on public transportation or a borrowed car
• Is also caring for children or older relatives

Now add extra clinic visits, labs, scans, and long days at a cancer center. Surveys show many patients cite financial and time burdens as major reasons for declining trials.
Those burdens fall hardest on people who already face income inequality, housing insecurity, or limited access to reliable transportation realities that disproportionately affect communities of color.

3. Acceptance and Trust: “Do I feel safe saying yes?”

Historical abuses in research, such as the Tuskegee syphilis study, have left deep and understandable mistrust in many communities. That mistrust can show up as fears about being a “guinea pig,” doubts about whose interests are being served, and concerns about exploitation.

Modern trials include informed consent, oversight committees, and ethical guidelines, but trust doesn’t magically appear just because the paperwork is better. Patients also worry about:

• Not getting the “real” treatment
• Unclear explanations about risks and benefits
• Language barriers or cultural misunderstandings

In surveys, many patients say they’re concerned about the risks of “less-tested treatments,” the time commitment, and the number of extra appointments.
All of that can layer on top of long-standing mistrust and make “no” feel like the safer choice.

What’s Being Done to Improve Clinical Trial Diversity?

Thankfully, this issue is not flying under the radar anymore. Advocacy groups, academic centers, government agencies, and patient communities are all pushing for more representative research.

Policy and Regulatory Efforts

In recent years, the U.S. Food and Drug Administration (FDA) has issued guidance encouraging sponsors to:

• Design trials with broader eligibility criteria
• Recruit from community hospitals and clinics, not just large academic centers
• Develop “diversity action plans” with specific goals for including underrepresented populations

Draft guidance released in 2024 outlined Diversity Action Plans as part of many drug and device trials, aiming to make inclusion more intentional rather than an afterthought.
Political debates and policy shifts have complicated the rollout, but the core message from scientific and patient communities is consistent:
diverse trials are scientifically better trials.

Community-Based Strategies

Beyond policy, a lot of the real work happens locally. Studies of interventions to increase minority participation in cancer trials have identified several promising strategies:​

• Patient navigators from the same community who can explain trials, help with logistics, and support decision-making.
• Partnerships with trusted organizations like churches, community groups, and local nonprofits to share information and host enrollment events.
• Language access providing materials and interpreters in patients’ preferred languages.
• Financial support for travel, lodging, childcare, and lost wages, sometimes funded by nonprofits or trial sponsors.
• Culturally tailored outreach that acknowledges history, respects values, and builds trust over time.

At some cancer centers, these efforts have doubled the proportion of Black patients in clinical trials over several years.
The lesson is clear: when you make participation possible and respectful, people show up.

How Patients, Clinicians, and Sponsors Can Help Right Now

For Patients and Families

You don’t have to be an expert in clinical research to advocate for yourself. A few practical steps:

• Ask the question. If you or a loved one has breast cancer, ask your oncologist directly: “Are there any clinical trials that might be appropriate for me?”
• Bring someone with you. A friend or family member can help you take notes, ask follow-up questions, and process information later.
• Clarify the basics. Ask about the goal of the trial, what’s known about the treatment so far, what the alternatives are, and what extra visits or tests are required.
• Talk about logistics. If travel, childcare, or time off work are potential deal-breakers, say so. Sometimes support programs exist that you won’t hear about unless you ask.

For Clinicians

Healthcare professionals play a huge role in who gets access to trials. Helpful actions include:

• Checking for relevant trials early, not just when standard treatments are exhausted
• Discussing trials with all eligible patients, not just those who “seem interested” or match a mental stereotype of who participates
• Using plain language and checking for understanding, especially when English is not a patient’s first language
• Working with navigators and social workers to address transportation, insurance, or financial concerns

For Sponsors and Institutions

Trial sponsors and research institutions have the most power to change the system. They can:

• Design trials that reflect real-world patients, not just the healthiest, easiest-to-enroll group
• Open trial sites in community oncology clinics and safety-net hospitals
• Build diversity goals into study design and track progress transparently
• Budget from the beginning for outreach, navigation, and patient support

In short, diversity should be baked into the recipe, not sprinkled on top at the last minute.

Why This Fight for Diversity Is About Justice Not Just Data

It’s easy to talk about “representation” in abstract terms, but in breast cancer, it translates into very concrete outcomes:

• Who gets access to new therapies first
• Whose side effects are recognized and managed effectively
• Whose survival improves and whose does not

Racial and ethnic disparities in breast cancer mortality are stubborn. Black women in the U.S. are more likely to die of breast cancer than white women, even when they have similar stage at diagnosis.
If the trials that shape our treatment guidelines don’t adequately include those most at risk, we risk reinforcing those disparities instead of reducing them.

Clinical trial diversity, then, is not a “nice-to-have.” It is one of the tools we must use to move toward more equitable outcomes along with better screening, quality care for all insurance types, culturally responsive support services, and addressing broader social determinants of health.

Experiences from the Front Lines of Diverse Breast Cancer Trials

Statistics are important, but they don’t tell you what it actually feels like to navigate a clinical trial as a patient from an underrepresented community. While every story is unique, certain themes pop up again and again in patient narratives and clinician experiences.

A Long Drive, a Big Decision

Imagine a woman in her early 50s who lives two hours from the nearest comprehensive cancer center. She’s Latina, works in a food service job, and has just been told she has triple-negative breast cancer a more aggressive subtype that often hits younger women and women of color.

Her oncologist mentions a clinical trial: a new combination therapy that might offer better outcomes, but it requires more frequent visits and extra tests. She’s worried about missing work, losing income, and arranging childcare. She also isn’t sure what it means to be “on a trial” and whether she’ll get a “real treatment” or a placebo.

When the clinic has a Spanish-speaking navigator who can explain the details, line up transportation support, and help her talk with her employer, the trial suddenly feels less like a maze and more like an option. When no such support exists, the safest path can look like sticking with whatever is available close to home even if the trial might have offered better odds.

Trust Built One Conversation at a Time

For many Black patients, trust is not something that appears just because a brochure says, “We care about diversity.” Survivors describe how helpful it is when:

• A clinician takes the time to acknowledge historical abuses in research instead of pretending they never happened.
• They see staff members and physicians who look like them or speak their language.
• They are invited into a genuine conversation about risks and benefits, not pressured into signing forms they barely understand.

One breast cancer survivor described how a doctor sat down, closed the laptop, and said, “You are not a guinea pig. Here’s what we already know about this drug, here’s what we don’t know yet, and here’s what will happen if you decide it’s not for you.” That level of respect turned a terrifying idea into a considered choice.

Clinicians Caught in the Middle

On the provider side, oncologists and nurses often juggle impossible schedules while trying to offer cutting-edge care. Many want to enroll more diverse patients but run into:

• Complex eligibility criteria that automatically exclude patients with common chronic conditions
• Trials opened only at distant sites, even within the same health system
• Limited time to explain trial options in already packed clinic visits

Some clinicians describe the frustration of knowing that a trial exists but being unable to get patients to it because of transportation, insurance hurdles, or rigid protocols. Others share the satisfaction of seeing a patient who almost said no thrive on a trial thanks to extra support from navigators and social workers.

Why Personal Stories Matter for the Future

These experiences remind us that “diversity” is not just a demographic pie chart on a grant application. It’s the story of who gets called back, who gets a second opinion, who hears about a trial, and who has the support to say “yes” or “no” for reasons that truly align with their goals and values.

When breast cancer clinical trials make room for more voices and more experiences, everyone benefits. We learn more about how treatments work across different bodies and backgrounds. We spot side effects sooner. We discover dosing or combinations that might not have been obvious in a homogeneous group. In short, we move closer to a world where “standard of care” really is designed for the full spectrum of patients facing breast cancer.

Getting there will take policy changes, institutional accountability, and daily, human-scale efforts from the receptionist who helps reschedule an appointment, to the sponsor who budgets for travel assistance, to the patient who asks, “Is there a trial I should know about?” Diversity in breast cancer clinical trials is not just a checkbox; it’s a path toward more just, more effective cancer care for all.

Conclusion

Breast cancer clinical trials are the engine that powers tomorrow’s treatments. If that engine runs mostly on data from one slice of the population, we miss crucial information and risk widening already unacceptable gaps in outcomes.
Despite some encouraging progress, racial and ethnic minorities remain underrepresented in breast cancer research, even as they bear a disproportionate burden of aggressive disease and worse mortality.

Increasing diversity in trials requires more than inspirational slogans. It demands redesigned protocols, community partnerships, financial and logistical support, culturally competent communication, and policy frameworks that make inclusion a requirement, not an afterthought.
Patients, clinicians, sponsors, and policymakers all have a role to play.

The bottom line: when we insist that breast cancer clinical trials reflect the real world, we don’t just make the data prettier we make the science stronger, the treatments smarter, and the future fairer.