The Society for Women’s Health Research (SWHR) submitted comments in response to a newly released U.S. Food and Drug Administration (FDA) draft guidance for industry that provides recommendations regarding the inclusion of premenopausal women in breast cancer clinical trials. SWHR is supportive of the FDA’s proposed recommendation to improve inclusion rates of premenopausal women.
Premenopausal women with hormone-receptor positive (HR+) breast cancer are often underrepresented in cancer treatment studies. Because of the poor inclusion rates for younger women in breast cancer clinical trials, treatment in this population is frequently based on studies conducted on postmenopausal patients, despite the fact that cancer pathophysiology may be different in premenopausal versus postmenopausal women. Therefore, SWHR strongly supports this draft guidance, which warns against the use of menopausal status as exclusion criteria and stipulates that “[p]remenopausal women with adequate estrogen suppression and postmenopausal women should be equally eligible and included in clinical trials for drugs or combinations manipulating the hormonal axis.”
Read The Comments
