Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens

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.

Timeline

Start

2021-12-14

Primary completion

2026-07-31

Completion

2027-07-31

Publications

• Background Fabian CJ, Nye L, Powers KR, Nydegger JL, Kreutzjans AL, Phillips TA, Metheny T, Winblad O, Zalles CM, Hagan CR, Goodman ML, Gajewski BJ, Koestler DC, Chalise P, Kimler BF. Effect of Bazedoxifene and Conjugated Estrogen (Duavee) on Breast Cancer Risk Biomarkers in High-Risk Women: A Pilot Study. Cancer Prev Res (Phila). 2019 Oct;12(10):711-720. doi: 10.1158/1940-6207.CAPR-19-0315. Epub 2019 Aug 16.
• Background Gajewski BJ, Kimler BF, Koestler DC, Mudaranthakam DP, Young K, Fabian CJ. A novel Bayesian adaptive design incorporating both primary and secondary endpoints for randomized IIB chemoprevention study of women at increased risk for breast cancer. Trials. 2022 Dec 5;23(1):981. doi: 10.1186/s13063-022-06930-5.
• Fabian CJ, Mudaranthakam DP, Gajewski B, Young K, Winblad O, Khan SA, Garber JE, Esserman LJ, Yee LD, Nye L, Powers KR, Ranallo L, Kreutzjans AL, Pittman K, Altman C, Metheny T, Zelenchuk A, Komm BS, Kimler BF. Overcoming challenges in conducting early phase breast cancer prevention trials: Bazedoxifene and conjugated estrogens vs waitlist control. Contemp Clin Trials. 2024 Nov;146:107697. doi: 10.1016/j.cct.2024.107697. Epub 2024 Sep 17.

Drugs

Indications