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Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens

Research Group

Breast and Gynecologic Cancer

Status

Active, not recruiting

NCT ID

NCT04821141

Women at risk for development of breast cancer and experiencing vasomotor menopausal symptoms (hot flashes) will be randomized to bazedoxifene (BZA) plus conjugated estrogens (CE) for 6 months versus a wait list control. Two risk factors for development of breast cancer will be studied pre-study and after 6 months: fibroglandular volume (FGV) on mammogram as assessed by Volpara software and proliferation by Ki-67 immunocytochemistry in benign breast tissue acquired by random periareolar fine needle aspiration (RPFNA). Change in biomarkers will be compared between groups.

Intervention

Bazedoxifene and Conjugated Estrogens

Condition

Risk Reduction, Breast Cancer

Investigators

Carol J Fabian, MD

See list of participating sites