Phase 2 Study of Low Dose Tamoxifen With or Without High Dose Omega-3 Fatty Acids to Reduce Breast Cancer Risk in Overweight Postmenopausal Women

What this Trial Is About

Researchers are evaluating the use of low dose tamoxifen, with or without high dose omega-3 fatty acids, to reduce the risk of breast cancer in postmenopausal women who are overweight or obese and at increased risk for developing breast cancer. The study aims to understand how these treatments affect markers like serum adiponectin and insulin-related functions, as well as changes in breast tissue gene expression. This is a phase II randomized trial focusing on prevention. Participants are randomly assigned to one of two groups. Group 1 receives tamoxifen once daily by mouth for 180 days, with an option to continue for up to 60 extra days if needed. Group 2 receives tamoxifen once daily plus omega-3 fatty acids twice daily for the same duration and extension possibility. All participants undergo mammography screening and have random periareolar fine needle aspiration RPFNA and blood sample collection at the start and during the study. During the study, participants are monitored through blood tests, breast tissue sampling, and mammography to assess changes in adiponectin levels, insulin resistance and sensitivity, estrogen response gene index, and other biomarkers. After completing the treatment phase, participants have a follow-up visit 21 to 35 days later. The study measures changes from baseline to the end of treatment over six months and tracks potential effects on various biological markers related to breast cancer risk.

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