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FDA In Brief: FDA Encourages Inclusion of Premenopausal Women in Breast Cancer Clinical Trials

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October 7, 2020

Media Inquiries:  Chanapa Tantibanchachai,  202-384-2219

The following quote is attributed to Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research:

“Today, the U.S. Food and Drug Administration issued draft guidance encouraging the inclusion of premenopausal women in breast cancer clinical trials that investigate the efficacy of hormonal drug and biological products. When finalized, the guidance will provide recommendations for industry to generate additional data that will support the efficacy and safety of drugs and biologics for premenopausal women with breast cancer.

Historically, premenopausal women have been excluded from clinical trials that investigated the efficacy of hormonal drugs for the treatment of hormone positive breast cancer, largely due to concerns about potential differences in how these hormonal drug and biological products would behave in premenopausal versus postmenopausal women. This exclusion resulted in delays in availability of these therapies for premenopausal women. .

We believe that with sufficient estrogen suppression, hormonal drug and biological products are likely to have similar efficacy and safety in premenopausal women as in postmenopausal women. Therefore, premenopausal women should be included in these clinical trials.

Once finalized, we hope that the recommendations in the draft guidance will encourage expanded drug development for the treatment of breast cancer in premenopausal women."

Additional Information

  • Today, the FDA issued a draft guidance document, “Premenopausal Women with Breast Cancer: Developing Drugs for Treatment,” which, when finalized, will provide recommendations to sponsors designing clinical trials of drug and biological products to treat breast cancer.
  • The draft guidance, when finalized, will provide sponsors with recommendations regarding the inclusion of premenopausal women, as defined by serum hormonal levels, in breast cancer clinical trials.

Related Information

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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