drugset / Trial / NCT06184750

Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial

NCT06184750

Phase 2 Recruiting 200 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelPrevention

Summary

This phase II trial evaluates response-guided low-dose tamoxifen for reducing breast density in women who are at higher than average risk for breast cancer. Increasing breast density is a well established risk factor for breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen has been shown to reduce breast density, even at reduced dosages, and is approved for the prevention of breast cancer.

Timeline

Start
2024-09-27
Primary completion
2028-03-31
Completion
2028-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tamoxifen Small molecule 5 mg Oral
Subject Tamoxifen Small molecule 10 mg Oral
Subject Tamoxifen Small molecule 20 mg Oral