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The guidance provides recommendations for including premenopausal women in breast cancer clinical trials.
FDA published final guidance on June 17, 2021 for the development of treatments for breast cancer. The guidance offers recommendations for including premenopausal women in clinical trials of breast cancer drugs and biological products. The agency states in the guidance that menopausal status should not be the reason for exclusion from breast cancer clinical trials, and women with adequate estrogen suppression and postmenopausal women should be eligible for inclusion in clinical trials for drugs or combinations manipulating the hormonal axis.
The guidance does not address fertility and fertility preservations issues when treating premenopausal women with breast cancer. The agency recommends that a gynecologist be consulted during trial planning and monitoring.