Phase 2 Study Comparing Acolbifene 20 mg and Low Dose Tamoxifen 5 mg to Prevent Breast Cancer in High-Risk Premenopausal Women Aged 35 and Older

What this Trial Is About

Researchers are evaluating acolbifene compared to low dose tamoxifen to prevent breast cancer in premenopausal women at high risk. This phase IIA trial focuses on measuring changes in specific breast tissue genes and other markers related to breast cancer risk. The study addresses women with increased lifetime risk, including those with atypical hyperplasia or lobular carcinoma in situ, assessing effects on breast tissue, mammogram imaging, and blood samples. Participants are randomly assigned to receive either 20 mg of acolbifene or 5 mg of tamoxifen orally once daily for six months. During treatment, participants undergo 3D mammography and provide blood samples at screening and study end. They also have breast tissue sampled by random periareolar fine needle aspiration RPFNA during screening and within the first ten days of their menstrual cycle or at a convenient time if not menstruating. After treatment, participants are followed up between 21 and 35 days. Throughout the study, participants are monitored with mammograms, blood tests, and tissue analysis to assess changes in gene expression, mammographic density, hormone levels, and quality of life measures like hot flash scores. Safety and treatment effects are carefully tracked, including metabolic markers and drug levels. The total participant involvement includes screening, six months of treatment, and a short follow-up period to evaluate outcomes.

Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer