CHICAGO — Nobody offered Stephanie Walker a clinical trial when she was diagnosed with metastatic breast cancer. Nobody talked to her about what her options might be in clinical trials. She didn’t have a nurse or patient navigator, either, who could guide her through the treatment process. “It was just me, the oncologist, and his PA,” Walker, a registered nurse and patient advocate with the Metastatic Breast Cancer Alliance, said.
It frustrates her to look back on that time, especially in the context of a new study that she and other patients and patient advocates led that examines the experiences of Black women with metastatic breast cancer. According to the study results that Walker presented at the American Society of Clinical Oncology meeting on Monday, the majority of Black women with metastatic breast cancer don’t get enrolled into clinical trials. Only 40% of Black respondents said they were even offered a trial.
“But over 80% would consider joining a trial if they had known about one,” Walker said. “Nobody comes to talk to us about clinical trials.” The discrepancy, she said, arises at least partly because of institutional biases and preconceptions about Black patients. “I find that it has happened to me because I’m Black, you’ve already formulated an idea that I’m not educated to know about trials or maybe you think I don’t have the money to participate,” she said. Patients do not pay to participate in trials or for investigational drugs, but may incur costs for transportation, child care, or lose income from not working.
Researchers said the results from Walker’s study, called the BECOME Research Project, should force clinicians and scientists to see the racial biases that health care has both on a structural and a personal level. “One of the most amazing things about this is that this is not new information about African Americans specifically not being on trials,” said Robert Winn, the director of the Virginia Commonwealth University Massey Cancer Center. “But we’re becoming more conscious about — what role do we as trialists and health care professionals contribute? We as the health professions come up, subconsciously sometimes, with all this BS about why African Americans wouldn’t be on trials.”
In some ways, Walker was lucky, she said. She received her metastatic breast cancer diagnosis in July of 2015, and her doctors treated her with the hormone therapy drug fulvestrant. With it, she was able to continue working as a hospice nurse. Nearly seven years later, it’s still the only drug that she’s on. While she has occasional bone pain, she said, “it’s not as rough on me as I know other treatments can be.”
But a few years after her diagnosis, she experienced a stroke and a pulmonary embolism, which forced her to stop working as a nurse. With her new time, she started working as a patient advocate and, at the San Antonio Breast Cancer Symposium, met another metastatic breast cancer patient and epidemiologist, Marina Kaplan, “who is the reason behind BECOME,” Walker said. “Actually going into that symposium, she was in liver failure,” she recalled.
Kaplan had a poster on clinical trial and patient outcomes — but had very few Black participants in her study and wanted to better understand why. Walker agreed to help her survey Black patients on how they felt about clinical trials, but Kaplan never got the chance to do the study. “She passed away due to her disease in 2020,” Walker said.
But Walker wanted to continue. With a team from the Metastatic Breast Cancer Alliance, she interviewed patients, clinicians, researchers, and payers with a survey about experiences with clinical trials. The team sent out the survey through social media, breast cancer networks, nonprofits, and community clinics. They got responses from 424 patients. “I wanted 500 respondents – half Black and half white. I didn’t get those.” She did, though, get 104 people who self-identified as Black.
Of those 104, 90% said they had a high level of trust and satisfaction with their oncology care team, and 83% were somewhat or very likely to consider enrolling in a clinical trial. Walker’s team found that 71% of Black respondents said they trusted trials, compared to 91% of white respondents. Just 32% of Black respondents said they trusted that people of all races or ethnicities got fair treatment in clinical trials, compared to 56% of white respondents.
One of the most salient results was that 60% of Black respondents were never offered a clinical trial or had a discussion about one with their provider. “I wasn’t surprised, but of course I was disappointed,” said Julie Gralow, a breast medical oncologist and the chief medical officer for ASCO. “It reinforces that we’re not asking. These are for metastatic breast cancer patients. We don’t have cures there; everyone should be considered for trials in a setting where we don’t have cures from standard therapy.”
That might be happening for several reasons, both Gralow and VCU’s Winn said. For one, there may be anxiety around discussing clinical trials with patients of color. “This has been since I was a medical student at the University of Michigan — that was in the ’80s, man — that ‘they don’t trust us because of Tuskegee,’” Winn said. “Most folks don’t know what Tuskegee is, to be quite honest with you. Besides, the weird part of the trust issue is that if you ask people if they want to join a trial, you are actually building trust.”
Winn said much of the bias is often on the clinician and researcher side. “They’ll say, ‘Well, they can’t make it to the trials because it’s going to be extensive, and they’re going to need transportation.’ But how do you know that? The researcher’s already spoken for the patient and made up a story for why they can’t make it,” he said.
There are also biases in the way clinical trials are designed that make it harder for many people of color or people of low socioeconomic status to participate, Gralow said. “We need to make it easy for them to participate,” she said. “So many ridiculous things we do that aren’t necessary. Like these narrow windows that say this scan or that procedure has to be done exactly at 12 weeks plus or minus two days. It’s just not convenient for the patient — her day off is Friday, and she can’t get it plus or minus two days.”
And trials are also often not designed with inclusion of Black participants in mind, Walker said. For instance, the incidence of certain comorbidities that are higher among African Americans may result in exclusion from a trial even if it may not have an impact on a drug’s performance, Walker said. “We’re excluded a lot because of high blood pressure or diabetes or something,” she said. “I just want us to have a chance to live and have the quality of life like everybody else.”