The following excerpt was published on STAT News on January 27, 2026.

At the American Society of Clinical Oncology annual meeting last year, researchers presented the results of a large Phase 3 breast cancer clinical trial that led to the approval of inavolisib, an important new drug for breast cancer. In the study, inavolisib significantly improved survival rates among patients with hormone receptor-positive breast cancer who also carry a genetic mutation that makes them resistant to standard endocrine therapy. 

In the final slides of the presentation, the researchers noted that one of the limitations of the study was that it enrolled only 0.6% Black patients. In fact, more men were enrolled in this clinical trial than Black women.

As a Black oncologist, I was deeply disturbed by this data. Why were Black women not represented in a study that led to the approval of inavolisib, which had received breakthrough designation from the Food and Drug Administration, especially when data shows Black women have a 40% higher death rate than white women from breast cancer? The patients in this Phase 3 trial, which was later published in the New England Journal of Medicine and led to FDA approval, did not look like people who are diagnosed with breast cancer in the U.S. or around the world.

The challenge of underrepresentation in clinical trials is not new and has been increasingly recognized among the medical community as a flaw that must be remedied. Yet as those final slides demonstrated, very little progress has been made in ensuring that the population enrolled in clinical trials testing new cancer drugs is representative of the general population. There are more nuanced discussions about whether representation should reflect the distribution of disease incidence — the different proportions of people who are diagnosed with the disease annually — versus census distribution. Although these are valid considerations, it’s hard to argue that enrolling 0.6% Black women in a breast cancer trial is acceptable or offers meaningful representation.

Read the full First Opinion here.


Author

Yehoda Martei, MD, MSCE

Assistant Professor, Hematology/Oncology, Perelman School of Medicine


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