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FDA’s New Guidance Recommends Including Men in Breast Cancer Clinical Trials

New federal guidance recommends that breast cancer clinical trials be open to men – who are being diagnosed with and dying from the disease – but have largely been excluded from clinical trials.

An estimated 2,620 men will be diagnosed with breast cancer in 2020 and 502 will die from it in the US. Although breast cancer is less common in men than women, the survival rates are about the same for both genders, but men tend to be diagnosed at a later stage.

By including men in clinical trials, treatment options can be evaluated, and their care can be better informed by data collected and analyzed in trials. Currently, the treatment of men with breast cancer is generally based on clinical experience with breast cancer in females and studies done in females.

The guidance issued by the Food and Drug Administration this month incorporates recommendations made by Susan G. Komen last year. In a letter to the FDA, Komen wrote:

“It is critical that men with breast cancer have the same access to clinical trials as women…and eligibility for clinical trials of breast cancer drugs should allow for inclusion of both males and females. Men deserve to have treatment strategies based on data from studies conducted in males with breast cancer, not only women, and the option to enroll in a clinical trial.

“In order for clinical trials to benefit all patients, a diverse population of participants more fully representative of the population impacted by the disease being studied is needed to increase the widespread value and usefulness of trial results.”  

FDA’s guidance can be found here.