Research Group
Breast and Gynecologic Cancer
Sponsor
University of Kansas Medical Center
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov 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.
(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