Include Premenopausal Women in Breast Cancer Trials, FDA Advises
Sponsors developing drugs to treat breast cancer should consider including premenopausal women in trials, according to an FDA draft guidance released last week.
Menopausal status should not be the basis of trial exclusion, the guidance says, because hormone therapies administered to premenopausal women with adequate estrogen suppression are likely to have the same efficacy as in the postmenopausal population.
Stratification of randomization based on menopausal status at study entry may be appropriate, the guidance adds, if there are efficacy and/or safety concerns. Trials also should include an assessment of reproductive toxicity and collect data on long-term effects of breast cancer in premenopausal women.
Comments on the draft guidance are due Dec. 7.
To read the guidance, click here: https://bit.ly/3mfh7wi.