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# Include Premenopausal Women in Breast Cancer Trials: FDA
- URL: https://www.fdaweb.com/include-premenopausal-women-in-breast-cancer-trials-fda/
- Published: 2020-10-07T12:00:00.000Z
- Updated: 2026-09-14T16:31:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147824

FDA has published a draft guidance, *Premenopausal Women with Breast Cancer: Developing Drugs for Treatment*, with recommendations to sponsors developing drugs or biologic products regulated by CDER and CBER for treating breast cancer. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/premenopausal-women-breast-cancer-developing-drugs-treatment?ref=fdaweb.com) specifically includes recommendations on the inclusion of premenopausal women in breast cancer trials. The issues of fertility and fertility preservation when treating premenopausal women with breast cancer are outside the scope of the guidance and are not addressed, FDA says.