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

Summary

This phase IIA trial compares the effect of acolbifene versus low dose tamoxifen in preventing breast cancer in premenopausal women at high risk for developing breast cancer. The usual approach for patients at increased risk for breast cancer is to undergo yearly breast magnetic resonance imaging or ultrasound in addition to yearly mammogram. Premenopausal women at very high lifetime risk for breast cancer (greater than 50%) can consider preventive removal (mastectomy) of both breasts.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Breast Atypical Hyperplasia
• Breast Carcinoma
• Breast Ductal Carcinoma In Situ
• Breast Lobular Carcinoma In Situ

Eligibility basics and study details

Study type

Interventional

Phase

Phase 2

Ages

35 years and older

Sex

Female

Healthy volunteers

Not accepted

Sponsor

National Cancer Institute (NCI)

Last updated on ClinicalTrials.gov

July 7, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites