Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens

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, Laura Esserman, MD, Lisa D Yee, MD, Victoria L Seewaldt, MD, Sema Khan, MD, Judy Garber, MD

See list of participating sites