A landmark breast cancer drug trial that led to FDA approval enrolled only 0.6% Black patients, raising serious concerns about racial disparities in medical research. The Phase 3 study testing inavolisib, a breakthrough treatment for hormone receptor-positive breast cancer, included more men than Black women despite Black women having a 40% higher death rate from breast cancer than white women.
Medical oncologist Yehoda Martei from the University of Pennsylvania warns this pattern represents both a moral and scientific failure. Recent therapeutic trials show a troubling trend of declining Black patient enrollment. While the ASCENT trial for metastatic triple-negative breast cancer enrolled 12% Black patients, subsequent studies enrolled far fewer: KEYNOTE-522 included 4.8%, NATALEE enrolled 1.6%, and TROPION-Breast01 and DESTINY-Breast06 enrolled just 1.5% and 0.8% respectively.
This lack of diversity extends beyond Black women to harm rural populations, older adults, Hispanic women, and people from low and middle-income countries. When trial participants don’t reflect real-world diversity, the evidence guiding universal cancer treatment guidelines remains incomplete.
The exclusion threatens the foundation of precision medicine. Martei questions how treatment can be truly personalized when data excludes entire populations. Addressing this requires building long-term trust with underrepresented communities, liberalizing trial eligibility criteria, and training diverse clinical investigators. Programs like the Robert A. Winn Excellence in Clinical Trials Award aim to ensure future research reflects the full spectrum of people diagnosed with cancer.
See: “Sidelining Black women in clinical trials is not just a moral failure. It’s bad science” (January 27, 2026)Â
