Premenopausal Women with Breast Cancer: Developing Drugs for Treatment Guidance for Industry June 2021

GUIDANCE DOCUMENT

• Docket Number: FDA-2020-D-1553
• Issued by: Oncology Center of Excellence; Center for Biologics Evaluation and Research

This guidance provides recommendations to sponsors developing drugs or biological products regulated by CDER and CBER for the treatment of breast cancer. Specifically, this guidance includes recommendations regarding the inclusion of premenopausal women, as defined by serum hormonal levels (including but not limited to follicle-stimulating hormone and estradiol), in breast cancer clinical trials. The issues of fertility and fertility preservation when treating premenopausal women with breast cancer are outside the scope of this guidance and are not addressed.

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