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February 22, 1995

Estrogen Replacement Therapy in Breast Cancer Survivors

Author Affiliations

Food and Drug Administration Rockville, Md

JAMA. 1995;273(8):620-621. doi:10.1001/jama.1995.03520320027032

To the Editor.  —Dr Cobleigh and colleagues1 argue for clinical trials of ERT in breast cancer survivors. They state that "breast cancer survivors are no exception" with regard to potential for ERT benefits—in the treatment of menopausal symptoms and the prevention of osteoporosis and coronary heart disease—but that "practicing physicians who treat breast cancer survivors currently have no official justification to offer ERT."We agree that clinical trials are needed to address this issue and wish to note that on February 14,1992, the Division of Metabolism and Endocrine Drug Products (DMEDP) of the Food and Drug Administration convened its Fertility and Maternal Health Drugs Advisory Committee for public discussion of the issues involved. During the proceedings, the committee voted unanimously "yes" to the question: "Is it ethical to conduct well-designed clinical trials of hormone replacement therapy in women who have been treated for breast cancer, when a primary outcome

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