Breast cancer is rare in males, with less than one percent of all breast cancer cases occurring in male patients. Hence, they have been usually excluded from clinical trials. The US FDA has published draft guidance for including men in clinical trials of breast cancer drugs. It recommends that eligibility criteria for clinical trials of breast cancer drugs should allow for inclusion of both males and females.
It further recommends that “Scientific rationale should be included in the protocol when proposing to exclude males from breast cancer trials. FDA does not intend to consider low expected accrual rates of male patients with breast cancer to be a sufficient scientific rationale for excluding them from a clinical trial”. When males have not been included or when inclusion of males is very limited in clinical trials for a specific breast cancer drug It may be possible to extrapolate…
