FDA Amends Guidelines for Male Breast Cancer Clinical Trial Enrollment
Posted: Wednesday, August 19, 2020
On August 11, the U.S. Food and Drug Administration (FDA) made several guideline changes to its Draft Guidance calling for the inclusion of male patients in breast cancer clinical trials. Although breast cancer in men is rare, representing about 1% of total breast cancer cases, emerging research on the differences between male and female patients with breast cancer, including the time of diagnosis, led to the removal of the following statement: “The prognosis for males with breast cancer is similar to that for females with comparable stages of disease.”
The FDA also updated its existing recommendations for drug sponsor discussions and drug development plans. Currently, the guidance recommends having these discussions early on with the relevant product center at the agency. The updated guidelines suggest having discussions that include the number of male patients with breast cancer enrolled in the trial as well as the type of data collection to be used for male patients.
For more information on the updated FDA recommendations, visit www.fda.gov.
