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 triple negative breast cancer (TMNT) phase 3. Because of her medical history, Latoya knew early in her treatment that she wanted to participate in a clinical trial. But her oncologist never mentioned a clinical trial and dismissed the idea when she mentioned it.
“I was emailing him about various tests and saying I didn’t meet the requirements. I didn’t even consider it” Latoya said.
Then Latoya attended an introductory conference for a new immunotherapy drug for people with CMNT. After learning that most of the people she spoke to were in a clinical trial for that drug, Latoya found a new oncologist who was also black. After working with her new oncologist, Latoya is now participating in a clinical trial that’s right for her.
Latoya’s story sadly reflects the reality of many Black and Hispanic women who don’t have easy access to clinical trials for their potentially life-saving breast cancers. researchers of a study found that black participants were 38 percent underrepresented in breast cancer studies. And even though Black women make up 13 percent of the population, they participated in just 2 to 9 percent of breast cancer clinical trials that led to the approval of four new breast cancer treatments in 2020. Likewise , Hispanic or Latino people make up 20% of the US population, but they had only 0 to 9% participation in those same trials.
Clinical trials are very important because many of the drugs and immunotherapies they offer represent the latest searches and treatments may be more effective than regular cancer treatments. Approximately between 25 and 30% of drugs used in Phase 3 clinical trials are approved by the US Food and Drug Administration (FDA). Thus, a lack of representation in breast cancer clinical trials means fewer Black and Hispanic women may have access to advanced, potentially life-saving treatments.
“Although black women don’t have the highest diagnosis rate, we are (about) 40 percent more likely to die of breast cancer,” she said. Monique Gary, MD, a breast surgery oncologist and medical director of the Grand View Health/Penn Cancer Network Cancer Program. Black patients have the highest chance of dying from breast cancer and unfortunately clinical studies don’t reflect this.
Dr. Gary says poor communication is part of the problem. “The number one reason black women don’t participate in clinical trials is because they are simply not asked to participate,” said Dr. Gary.
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Why aren’t people of color 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 willing to participate in a clinical trial. However, only 5 in 10 reported that they knew of an ongoing clinical trial and only 4 in 10 reported that a member of a cancer team would let them know if one was available. Although there is a history of medical distrust in the black communityit seems that it is lack of awareness rather than distrust that causes much of the underrepresentation.
Another major factor causing underrepresentation 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 an institution in their community, even when there are NCI-designated cancer centers near them,” Dr. Gary said. “They prefer the care of doctors and staff who look like them.”
Another hurdle: Many clinical trials have criteria that can exclude Black and Hispanic women.
“The studies exclude candidates with (two or more medical conditions), such as high blood pressure, which are very common for black people,” said Damé Idossa, a breast oncologist and associate professor of medicine at the University’s School of Medicine. of California. Minnesota.
Many pharmaceutical companies do not seek participation in clinical trials of people with 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 consider people who will actually take the drug. For example, a black woman with diabetes might be barred from a clinical trial for a specific drug, but she would likely be prescribed the drug once it’s approved by the FDA. This means that many black patients may be taking medications that could cause bad reactions that haven’t been studied for other conditions.
Even for women who know about and have access to clinical trials, substantial indirect costs, especially in terms of time and money, can make it difficult for them to participate.
“From the perspective of the patients, there are many (requirements) to participate in clinical trials. Treatments are free, but there are more blood draws and imaging. There may be indirect costs that are not always considered, such as work permits, paying for parking and fuel, or finding childcare for patients with children,” said Dr Idossa.
Lack of diversity in clinical trials causes less personalized care
The lack of diversity in clinical trials also limits opportunities for personalized medicine and care for Black and Hispanic breast cancer patients. For example, between 5 and 10 out of 100 cases of breast cancer they are caused by inherited genetic mutations, most commonly in the gene BRCA1 or BRCA2. THE personalized medicine seeks to diagnose and treat breast cancer, using a patient’s genetic makeup and the genes in the cancer cells. But most of the data doesn’t have a good representation.
According to Dr Idossa, much of what we know about genetic mutations comes from a European population that didn’t have much variety in their DNA. He added that when non-white patients undergo DNA testing, they can sometimes receive a variant of uncertain significance (VSI), because it is often based on European standards.
AND result with a VSI it means that a mutation was found during genetic testing, but it is not known whether it is a non-cancerous mutation or linked to cancer. Research has shown that Hispanic and Asian women have the highest amount of results with VSI and black women have the highest rates of VSI results, which are in turn associated with cancer.
“You can’t tailor medicine for a genome you don’t have and biology you don’t understand,” said Dr. Gary. So our treatments will be less refined, because our disease is not well understood.”
Solutions for the future
There are steps the medical and pharmaceutical industries can take to make cancer trials more inclusive.
For starters, Dr. Gary and Dr. Idossa said drug companies can participate in partnerships with community organizations that are targeted more by Black and Hispanic breast cancer patients.
“There is a need to focus on intent in how we train people, and we need to have staff who can actually do these tests in the communities, clinics and hospitals where most patients actually live,” said Dr. Idossa.
Companies that manage trials should invest more in marketing and educating the communities that need these trials.
Dr Idossa said researchers should seek to develop good and meaningful relationships with marginalized communities. Having a previous, long-term, trusting relationship can make it easier to increase the safety of trial participants and can make it easier for Black and Hispanic women to participate in clinical trials.
Healthcare professionals (HCPs) should also review implicit biases and communication styles. Healthcare providers should offer information to cancer patients without them deciding for themselves whether a patient would be interested or a good candidate.
“We (Black and Hispanic patients) need to take the necessary steps to participate in these studies now. People are ready. We have to seize these moments,” Dr. Gary said.
Unfortunately, inequalities in breast cancer have been around for years, but we have the opportunity to make tangible changes that can help save more lives and provide Black and Hispanic people with breast cancer with the care and treatment they deserve.
This resource has been prepared with support from Merck.
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