Clinical Trial

Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated October 29, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2021-03-25; most recent amendment 2025-10-27.
Status change: Recruiting → Active, Not Recruiting 2025-10-27
Status change: Not Yet Recruiting → Recruiting 2022-01-19
Trial Details
NCT Number NCT04821141
Lead Sponsor University of Kansas Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Risk Reduction, Breast Cancer
Enrollment 120 participants
Start Date 2021-12-14
Primary Completion 2026-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-10-29