Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Running, not enrolling · Phase 2
Conditions studied: Risk Reduction, Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT04821141
- Run by
- University of Kansas Medical Center
- People needed
- 120
- Starts
- 2021-12-14
- Expected to finish
- 2027-07-31
- Last updated by the study team
- 2025-10-29
Who can join
Age: 45 and older, up to 64. Sex: female. Healthy volunteers: accepted.
Where it is running
- City of Hope Medical Center — Duarte, California, United States
- University of California San Francisco — San Francisco, California, United States
- Northwestern Medical Center — Chicago, Illinois, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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