drugset / Trial / NCT06195306

Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction

NCT06195306

Phase 2 Recruiting 66 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelPrevention

Summary

This phase II trial evaluates tamoxifen, with or without omega-3 fatty acids, for reducing risk of breast cancer among postmenopausal and overweight or obese women who are at increased risk of developing breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen is approved by the Food and Drug Administration for prevention of breast cancer in women at increased risk. Omega-3 fatty acids have been shown to decrease the amount of fats made in the liver. Omega-3 fatty acids may work to prevent cancer in overweight or obese individuals. Tamoxifen with or without omega-3 fatty acids may be effective at reducing risk of breast cancer among women who are postmenopausal, overweight or obese, and at increased risk.

Timeline

Start
2025-07-28
Primary completion
2027-01-01
Completion
2028-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Lovaza Other / unclassified Oral
Subject Tamoxifen Small molecule Oral