NCHR’s Public Comments on Breast Cancer Treatment for Premenopausal Women

December 7, 2020

National Center for Health Research’s Comments on the Food and Drug Administration’s Draft Recommendation Statement Regarding Developing Drugs for the Treatment of Breast Cancer in Premenopausal Women

[Docket number FDA-2020-D-1553] 

We are writing to express our views on the Food and Drug Administration’s (FDA) draft recommendation statement regarding developing drugs for the treatment of breast cancer in premenopausal women. The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest. 

We strongly endorse the FDA recommendation that premenopausal women should be included in breast cancer drug development programs. As stated by the FDA, hormonal drugs administered to premenopausal women with adequate estrogen suppression are likely to have generally the same efficacy and safety profile as in postmenopausal women. However, since estrogen suppression in premenopausal women is likely to cause menopausal symptoms and infertility, the physical and psychological impact of such effects deserves careful research attention. The inclusion of premenopausal women in breast cancer drug development programs will allow the clinical trials to be applicable to a larger population, bring access to safe and effective breast cancer therapies to premenopausal women with breast cancer, and at the same time provide valuable information of importance to premenopausal breast cancer patients so that they can make informed treatment choices. 

We support the FDA recommendation that stratification of randomization based on menopausal status at entry, because the key question to be answered is the extent to which benefits outweigh the risks for subpopulations of premenopausal women. We also agree that information on the long-term clinical effects of breast cancer drugs in premenopausal women, such as fertility and sexual health, as well as cardiac or bone health effects, must be collected to determine the possible long-term adverse events. We suggest that there should also be racially/ethnically diverse samples of women when collecting these long-term data, in order to assess whether the effects are similar or different for women across racial/ethnic groups.

In conclusion, we strongly recommend that clinical trials on breast cancer treatments should strive to include pre-menopausal women. By including sufficient numbers of premenopausal women, clinical trials should provide meaningful information to women of different ages and races.