Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Status:
Not yet recruiting
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
Summary
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.