Effect of Oral (Z)-Endoxifen in Premenopausal Women With Measurable Breast Density

Summary

This is a randomized, double-blinded, placebo-controlled dose-response efficacy study of oral (Z)-endoxifen in premenopausal women with measurable breast density. There will be 5 in-clinic visits (Screening, Day 1, Months 1, 3 and 6) and 3 self-report visits (Months 2, 4 and 5). Standard of care mammograms will be used for the screening mammogram as well as the 24-month follow up visit.

Timeline

Start

2021-12-21

Primary completion

2024-06-14

Completion

2026-03-12

Publications

• Hall P, Hammarstrom M, Bergqvist J, Czene K, Eriksson M, Gabrielson M, Tapia J, Quay S, Nash S, Backlund M. Endoxifen for mammographic density reduction-results from the KARISMA endoxifen trial. J Natl Cancer Inst. 2026 Apr 27:djag087. doi: 10.1093/jnci/djag087. Online ahead of print.

Drugs

Indications