Why we need more Black and Hispanic women in breast cancer clinical trials
Why we need more Black and Hispanic women in breast cancer clinical trials
In July 2021, Latoya Bolds Johnsona Washington, DC area physician assistant was diagnosed with stage 3 triple negative breast cancer (TNBC). Because of her medical background, Bolds-Johnson knew early in her treatment that she wanted to participate in a clinical trial. But his oncologist never brought up a clinical trial and shut down the idea when he brought it up.
“I’d email him about several tests and he would dismissively say I wasn’t qualified. It just wasn’t even a consideration,” Bolds-Johnson said.
Then Bolds-Johnson attended a conference that introduced her to a new immunotherapy drug for people with TNBC. After learning that most of the people she spoke to had received clinical trials for this drug, Bolds-Johnson found a new female oncologist who is also a woman of color. After working with her new oncologist, Bolds-Johnson is now participating in a clinical study that’s right for her.
Bolds-Johnson’s story sadly reflects the reality of many Black and Hispanic women who don’t have easy access to potentially life-saving clinical trials for their breast cancer. Researchers in one study found that black participants were 38 percent underrepresented in breast cancer studies. And, despite making up 13% of the population, only 2% to 9% of Black women participated in breast cancer clinical trials leading to four new breast cancer treatments being approved in 2020. At the same Thus, Hispanics or Latino Americans make up nearly 20% of people in the U.S. population, but they were 0% to 9% of participants in those same trials.
Clinical trials are so important because many of the drugs and immunotherapies they offer represent the latest searchesand treatments may be more effective than standard cancer treatments. About 25%–30% of drugs used in Phase 3 clinical trials end up being approved by the Food and Drug Administration (FDA). So, a lack of representation in breast cancer clinical trials means fewer Black and Hispanic women can access cutting-edge treatments that could save their lives.
“Although black women are not diagnosed at the highest rate, we are (about) 40% more likely to die of breast cancer,” she said. Monique Gary, MD, breast surgery oncologist and medical director of the Grand View Health/Penn Cancer Network Cancer Program. Black patients have the highest probability of dying from breast cancer and unfortunately clinical studies don’t reflect this.
Gary said poor communication is part of the problem. “The number one reason black women aren’t enrolled in clinical trials is because they simply aren’t asked to be part of the trials.” Gary said.
Read “We Need More Black Women in Clinical Trials” >>
Why aren’t black people participating in breast cancer clinical trials?
A survey of Alliance Against Metastatic Breast Cancer found that 8 out of 10 black people living with metastatic breast cancer were open to participating in a clinical trial. However, only 5 in 10 reported that they were even aware of an ongoing study, and only 4 in 10 reported that a member of an oncology team has told them of one. While there is a history of medical distrust in the black communityit seems that it is lack of awareness rather than distrust that drives much of the underrepresentation.
Another major factor driving low representation in clinical trials comes from the lack of available studies in community clinics serving Black and Hispanic people with cancer.
“People of color are more likely to receive cancer treatment at their community institution, even when there are National Cancer Institute (NCI) designated cancer centers in their vicinity,” Gary said. “They want to go with more doctors and staff than they look like,”
Another hurdle: Many clinical trials have criteria that can exclude Black and Hispanic women.
“The studies exclude candidates with (two or more health conditions), such as high blood pressure, that are highly prevalent among blacks,” said Damé Idossa, a breast oncologist and assistant professor of medicine at the University’s School of Medicine. University of Minnesota.
Many drug companies won’t use people in clinical trials who have other medical conditions because they are concerned about how the experimental therapy might interact with other drugs or affect other medical conditions.
However, this exclusion does not take into account the people who will actually take the medicine. For example, a black woman with diabetes may be barred from a clinical trial for a particular drug, but she will likely still be prescribed the drug once it’s approved by the FDA. This means that many black patients may be taking medications that could lead to adverse reactions to other conditions that haven’t been studied.
Even for women who have knowledge of and access to trials, substantial indirect costs, especially time and money, can make it difficult for them to participate.
“From a patient factor perspective, it takes a lot to be on trial. Treatments are free, but there are more blood draws and imaging. There may be indirect costs that you don’t always think about, such as taking more time off work, paying for parking and gas, or finding childcare for patients with children,” Idossa said.
Lack of diversity in clinical trials leads to less personalized care
The lack of diversity in clinical trials also limits opportunities for personalized medicine and care for Black and Hispanic patients with breast cancer. For example, between 5-10 out of 100 cases of breast cancer arise from inherited genetic mutations – most commonly on the BRCA1 or BRCA2 gene. Personalized medicine aims to diagnose and treat breast cancer, using a patient’s genetic makeup and the genes in the cancer cells. But most of this data is not representative.
According to Idossa, much of what we know about genetic mutations comes from a European population that didn’t have much variety in their DNA. She added that when non-white patients undergo DNA testing, they can sometimes receive a result variant of unknown significance (VUS), because it is often based on European standards.
A VUS result it means that a mutation was found during genetic testing, but it is not known whether it is a non-cancerous mutation or related to causing cancer. Research has shown that Hispanic and Asian women have the most VUS resultsand black women have the highest rates of VUS findings that are ultimately related to cancer.
“You can’t tailor medicine for a genome you don’t have and a biology you don’t understand,” Gary said. “And so our treatments will be less and less refined, because our disease is poorly understood.”
Solutions for the future of cancer clinical trials diversity
There are steps the medical and pharmaceutical industries can take to make breast cancer trials more inclusive.
For starters, Gary and Idossa said drug companies can engage in partnerships with community organizations that Black and Hispanic breast cancer patients go to the most.
“There is a need to focus on intentionality in how we train people and staff who can actually do these tests in the communities, clinics and hospitals where most of our patients actually live,” Idossa said.
Companies that conduct clinical trials need to invest more in marketing and educating the communities that need these trials.
Idossa said researchers should aim to build deep and meaningful relationships with marginalized communities. Having a long-standing, reliable relationship beforehand can make it easier to build participant confidence in trials and facilitate the recruitment of Black and Hispanic women into clinical trials.
Healthcare professionals (HCPs) also need to control implicit biases and communication styles. Healthcare providers would have to offer information to cancer patients without deciding for themselves whether a patient would be interested or a good candidate.
“It’s up to us now to take the necessary steps to take those steps to involve now[Black and Hispanic patients]in these studies. People are ready. I think we need to capitalize on that momentum” Gary said.
Unfortunately, disparities in breast cancer have been around for years, but now we have the opportunity to make tangible changes that can help save more lives and give Black and Hispanic people living with breast cancer the care and treatment they deserve.
This resource was created with support from Merck.
- Clinical Trials >
- Why women are needed in COVID-19 clinical trials ›
- We need more black women in clinical trials ›
- COVID-19 and the Growing Importance of Diverse Participation in Clinical Trials ›
- Why diversity in clinical trials matters ›