The US FDA has published draft guidance for including men in clinical trials of breast cancer drugs.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 findings to include male patients in the FDA approved indication for the drug where no
difference in efficacy or safety is anticipated between males and females based on the mechanism of action of a drug. The use
of extrapolation should be supported by data from earlier stages of development (e.g., nonclinical testing), literature, or both.
●Further data may be necessary to support extrapolation of findings to support an FDA-approved indication for male patients
with breast cancer where there is a concern for differential efficacy or safety between males and females.