Ethnic, Racial, and Sex Diversity Needed in Breast Cancer Clinical Trials

A lack of diversity in breast cancer clinical trial enrollment, whether it be lacking racially diverse populations or not including male patients, may prove detrimental to survival outcomes and when selecting therapies for select patient subgroups, according to Paolo Tarantino, MD.

Specifically, he noted that including diverse populations is important to fully understand how drugs benefit different patient groups. Tarantino, a medical oncologist at Dana-Farber Cancer Institute, noted his desire to see novel therapy indications expanded among these groups. Additionally, he indicated that this should become a more standard of practice over the next few years.

Transcript:

We’re learning more and more that breast cancer can differ biologically in patients of different races, and ethnic origins. In general, it’s important to focus our attention and research efforts on these topics and ensure that trials can enroll a diverse population so that we can understand [if] there is a difference in the drugs’ benefit depending on these factors [via sub-analysis]. This is happening but, of course, it takes time. At Dana-Farber, we’re active in trying to develop trials that enroll in diverse areas. Whenever we design a trial, there are [trial] sites that are able to reach populations that we’re not able to reach in Boston. I do expect this to improve in the next few years and to be able [to conduct trials that] are powered to understand if certain drugs are interactive in different ethnic populations or races.

It's important to remember that 99% of breast cancers occur in women, but about 1% occur in men, and we don’t have enough data on these novel drugs in men; we do need those data. Men should always be allowed to enroll in these trials so that we can perform sub-analyses and understand if novel drugs are as active in women [as they are] in men who biologically also have different cancers and can also have poorer prognoses compared with women. It’s important to focus on all these diversities and to tackle them in the way we design clinical trials and the way we analyze the resulting data.