Barriers exist, but participation urgent in breast cancer clinical trials: report

14 October 2021

FiercePharma

Across four new breast cancer treatments approved by the FDA last year, 2% to 9% of patients in clinical trials for the drugs were Black Americans and 0% to 9% were Hispanic, according to a new report from Breastcancer.org. 

The online community for breast cancer patients repeated what has been documented more and more in recent years: Diversity in clinical trials needs to improve, especially because Black women are 40% more likely to die of breast cancer, the group said Tuesday. 

Despite all the awareness campaigns and repeated calls for more representation of people of color in clinical trials, multiple barriers still exist to participating in such studies, and the data on representation for approved treatments last year do not look to have improved much. 

Across four new treatments for breast cancer approved by the FDA last year, between 2% and 9% of trial participants were Black patients, despite the group comprising 13% of the U.S. population, and 0% to 9% of patients were Hispanic of Latinx, even though that group makes up 18.5% of the people living in the U.S, the organization reported. 

Immunomedics' triple-negative breast cancer treatment Trodelvy was one of the new drugs addressed in the report for lack of diversity. About 7% of the treatment's trial participants were Black patients despite Black women being "twice as likely as white women to be diagnosed" with that form of cancer, the organization said. Trodelvy was critical to Gilead's $21 billion acquisition of Immunomedics. 

The other three treatments approved (PDF) for various forms of breast cancer in 2020 included Seagen's Tukysa, Zionexa and Siemens' Cerianna and MacroGenics' Margenza. 

“This is a problem we can’t ignore. We want clinical trials to find the best treatments for everyone, not just the chosen few," said Fumiko Chino, M.D., an assistant attending radiation oncologist at Memorial Sloan Kettering Cancer Center, in the report. 

Across the broader spectrum of cancer treatments approved last year, 59% of patients in trials for the 18 drugs lived outside of the U.S. Enrolling patients from other countries that have different demographic makeups than the U.S. is another factor affecting the lacking representation of the U.S. population, the organization said in the report. 

Aside from sponsors and CROs not enrolling diverse patient sets, many hurdles exist for people of color even finding out about or being eligible to participate in such clinical trials, Breastcancer.org said. 

One big factor: Doctors don't present clinical trials, or they "assume people of color won't be interested in trials or that they face too many obstacles to participate," the report said.

"This can be a major barrier, because many people don’t know how to ask about, research, or find clinical trials on their own without a doctor’s support," the group wrote in the report. 

Strict eligibility criteria, travel limitations, limited time to take off from work, out-of-pocket costs, inequitable historical healthcare practices and other issues still exist as challenges to ensuring trials match the demographic makeup of the population, the report said. 

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