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Breast cancer clinical trials

“Clinical trials set the standards for breast cancer treatments, but barely include Black bodies…Which means that most breast cancer treatments have been and continue to be trialed on older white women,” says Ricki Fairley.

“A treatment that works for an older, earlier stage white patient may not work the same for a young Black woman. The truth is, we can’t know without more research and data. In order to test how drugs work on Black bodies and keep Black Breasties from dying at higher rates, we need more Black women in clinical trials. But sadly, many Black women are never even offered clinical trial participation by their doctors.

This is a matter of life and death for Black women. We need to participate in clinical trials, if not for ourselves, for future generations of young, Black Breasties: our daughters, sisters, nieces and friends. Young Black women shouldn’t have to continue to rely on drugs that were not designed for them.”

See “Ricki Fairley, Co-Founder of TOUCH, The Black Breast Cancer Alliance Shares Why Clinical Trial Participation Will Help Black Women Beat Breast Cancer” on the Ebony website (2022)

“Clinical trials are the main way scientists develop new and improved cancer treatments. Yet less than 5% of adults with cancer participate in clinical trials, and most who do are white. Disparities in clinical trial participation among Black women could be one of the reasons they have worse breast cancer outcomes than other racial and ethnic groups in the United States.”

Source: breastcancer.org

The clinical trial that saved Karen Peterson's life

When Karen Peterson’s Triple Negative Breast Cancer spread to her lungs, spine and ribs, “I went into gear to build a treatment plan. I was told I had a lot of fighter cells and they were sitting in the wings waiting to fight, but they needed a little help.”

Peterson talked her way into a new clinical trial, despite only a 4 percent chance it would work for her. “It was better than nothing, so I said why not? I got lucky.” The clinical trial tested a combination of two drugs that saved her life. 

“It’s important to take ownership of your health. Self-advocacy is very important. Self-advocacy saved my life.”

An emotional 5-minute video from the American Association for Cancer Research.

Her clinical trial changed standard of care for breast cancer

When Tammie Denyse was 39 and a single mother with three children, she was diagnosed with breast cancer.  After a lumpectomy, adjuvant chemotherapy and radiation therapy, her oncologist offered her an opportunity to participate in a clinical trial.

“I’m not blind to the history in this country of medical experimentation on Black people, and, at first, I was hesitant to participate in the study,” she recalled.  But when she found out that too few Black women were participating to know whether they were responding to the treatment, she joined the clinical trial.

The research changed the standard of care for women with breast cancer and minimized the impact of side effects on their lives. Denyse is now cancer-free.

“My experience with cancer empowered me to be assertive and to become an equal partner in the decision-making of my care, and I wanted other Black women experiencing a cancer diagnosis to have that same sense of empowerment.”

She and her sister launched Carrie’s TOUCH, a nonprofit breast cancer organization, to give a voice to Black women and to significantly increase the number of Black breast cancer survivors.

Source: Why Are Black Women Still Dying at Higher Rates Than White Women From Breast Cancer?

"I wasn't ready to die, I was the breadwinner for my family"

“I’m a miracle,” says Ricki Fairley. “After a double mastectomy, six rounds of standard of care chemotherapy, six weeks of radiation, and reconstruction, I was told that my triple negative breast cancer (TNBC) was gone. But almost exactly a year to the date of my initial diagnosis, the TNBC had come back on my chest wall. My doctor told me that I was now metastatic and to get my affairs in order—I had two years, at the most, to live.

This doctor had only seen two TNBC patients before me and both died within nine months. Her minimal experience with TNBC and lack of knowledge of Black Breast Cancer led her to believe that there were no treatment options left for me.

But I wasn’t ready to die. I was the breadwinner for my family and the rainmaker for my company. I felt the responsibility to give my daughter, who was still in college at the time, the education she deserved.

I did my own research and found the Triple Negative Breast Cancer Foundation, which recommended one of a very few oncologists in the US who understood TNBC. She put me on two experimental drugs that have now become standard of care treatments for TNBC. Today, I’m a ten-year breast cancer survivor with no evidence of disease.”

See “Ricki Fairley, Co-Founder of TOUCH, The Black Breast Cancer Alliance Shares Why Clinical Trial Participation Will Help Black Women Beat Breast Cancer” on the Ebony website (2022)

Why diversity matters in breast cancer research

Not being included in clinical trials may be one of the reasons that Black women have worse breast cancer outcomes than other racial and ethnic groups. Lack of diversity among clinical trial participants means that new cancer treatments are being tested in groups of people that are not representative of the broader patient population that will receive these treatments if they are approved.

“We need everyone appropriately represented because we want to make sure a therapy works the same way and the side effects are the same in different populations,” said Karen Winkfield, MD, executive director of the Meharry-Vanderbilt Alliance in Nashville, Tennessee. “Sometimes a medicine might work better in one population than another. We need to learn these things up front so we can give each patient the right medicine at the right time.”

Up until recently, women of color have been largely left out of breast cancer research, including treatment trials and other types of studies that help doctors understand risk and risk reduction. “The majority of research in breast cancer screening, treatment, and hereditary susceptibility has been conducted on women with European ancestry,” said Lisa Newman, MD, of Weill Cornell Medicine and New York-Presbyterian in New York City. “We therefore face major gaps in knowledge. For example, we don’t know whether African American women might benefit from modified breast cancer screening recommendations, and we have an inadequate understanding of the genetics of triple-negative breast cancer.”

“The reason we want diverse populations in clinical trials is that we want patients present with a range of genetic, social, economic, and geographic factors. We want all patients to benefit from clinical trials, and, when we assess new therapies, we want to understand how they will impact diverse populations,” said Lori Pierce, MD, of the University of Michigan and past president of the American Society for Clinical Oncology.

Source: “Special Report: Increasing Racial Diversity in Breast Cancer Clinical Trials” (BreastCancer.org)

In eight  clinical trials testing oral chemotherapy drugs for the treatment of breast cancer between 2009 and 2019, in which the race of the participants was recorded, less than four percent of the participants were Black or Hispanic women.
Source: “Cancer Disparities and Black American Representation in Clinical Trials Leading to the Approval of Oral Chemotherapy Drugs in the United States Between 2009 and 2019” by Veronica B. Ajewole et al. (2021)

Multiple factors may contribute to the underrepresentation of People of Color in breast cancer trials.

Lack of referrals
Clinical trial participants often learn about these studies from their doctors, but biases can influence which people doctors refer to clinical trials. Some doctors might assume that Black people are unwilling to enroll in cancer trials or unlikely to follow the study protocols. Doctors themselves may be unaware of available trials, which may be more significant for doctors who work at hospitals or other centers that serve underrepresented racial and ethnic minority groups.

Medical distrust
Even when they learn about clinical trials, some People of Color may be reluctant to participate due to concerns about the study or the wider medical system. This may reflect the history of medical racism in the U.S. If someone experiences bias or discrimination from their primary care physician or other healthcare professionals, this may also contribute to medical distrust.

Restrictive eligibility criteria
Clinical trials only accept people who meet certain eligibility criteria, such as an absence of type 2 diabetes or heart disease. People of Color are more likely than white people to have these conditions.

Financial barriers
Inadequate insurance coverage and other financial barriers may also prevent some Black females and others from participating in breast cancer research. Trial sponsors do not usually cover the costs of routine cancer care that someone may need while participating in a study. Participants may face travel-related expenses, such as transportation and lodging costs. They may need to take time off work or away from caregiving responsibilities to attend clinical trial appointments. People with a lower income may find it challenging to afford the loss of income or the cost of child care.

See “Increasing racial diversity in breast cancer clinical trials” by Heather Grey on the MedicalNewsToday website (2022)

When We Tri(al): a campaign to increase Black participation in clinical trials

“The purpose of our When We Tri(al) movement is to help our Black community understand the importance of breast cancer science.  Black women need to know that our breast cancer deserves special attention and we all together need to advance the science,” says Ricki Fairley, triple-negative breast cancer (TNBC) survivor and the Co-Founder and CEO of TOUCH, The Black Breast Cancer Alliance.

A 4-minute video from TouchBBCA.

For this Special Report, Breastcancer.org spoke with experts and clinical trial participants about why diversity in clinical research matters, and how you can overcome common barriers that may be preventing you from participating in a breast cancer clinical trial.

Interested in joining a breast cancer clinical trial, but feeling overwhelmed or don’t know where to start? Here are some common questions about the challenges people face in finding and participating in a clinical trial and some helpful tips on how to find trials and make participating easier:

  • When is the right time to consider a clinical trial?
  • How do I start the process of looking for a clinical trial?
  • What should I expect when applying to enroll in a clinical trial?
  • What can I ask of the trial coordinators to make it easier for me to participate in a trial?
  • What costs may be involved with participating in a clinical trial and who can help me navigate the financial and insurance issues?
  • What risks are involved with joining a trial and what safeguards help protect participants?
  • How can I find other women who have participated in clinical trials to talk with about their experiences?
  • How can I get support and make sure I get my questions answered at my appointments related to enrolling in a clinical trial?

“The low accrual of ethnic minorities, particularly Black Americans, in breast cancer clinical trials is problematic for several reasons,” says Lajos Pusztai, MD, co-director of the Center for Breast Cancer at the Yale School of Medicine.

 “For one, it means Black patients are not given equitable access to potentially lifesaving new treatments very early on. Secondly, it limits our ability to study potential differences in drug metabolism, toxicity, and efficacy between populations with different ancestries.”

See “Benefits of Pre-surgical Immunotherapy Were Independent of Race in Patients with Aggressive Breast Cancer” on the American Association for Cancer Research website (July 29, 2022)

“The purpose of our When We Tri(al) movement is to help our Black community understand the importance of breast cancer science.  Black women need to know that our breast cancer deserves special attention and we all together need to advance the science,” says Ricki Fairley, triple-negative breast cancer (TNBC) survivor and the Co-Founder and CEO of TOUCH, The Black Breast Cancer Alliance.

“Imagine a world where we have a drug that says ‘For Black Women’ on the label.  We won’t get that without participating in clinical trials. Our participation in clinical trials, changes the game through advancements and breakthroughs for all Black women diagnosed with breast cancer.

There are a lot of reasons for what we call Black breast cancer, including access to care, implicit bias and racism and how we’re treated by medical providers.

But a major reason is that the drugs that we have now were not adequately tested on Black bodies. There’s not enough research around how breast cancer treatment works in Black bodies and not enough science on how Black women experience breast cancer differently.  We need drugs that work better for us and we need more effective treatment options.”

A 4-minute video from TouchBBCA.

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