Phase 2 Study of Low Dose Tamoxifen +/- High Dose Omega-3 Fatty Acids in Overweight Postmenopausal Women at Increased Risk for Breast Cancer
National Cancer Institute (NCI)
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.
Description
PRIMARY OBJECTIVES: I. To investigate average change in serum adiponectin within the low dose tamoxifen (LDTAM) + high dose omega-3-acid ethyl esters (omega-3 fatty acids) arm. II. To study the beneficial effects of addition of high dose omega-3 fatty acids to LDTAM by comparing the relative difference in change in serum adiponectin in overweight and obese high-risk postmenopausal women randomized to 6 months of LDTAM or LDTAM + high dose omega-3 fatty acids. SECONDARY OBJECTIVES: I. To determine effect of LDTAM +/- high dose omega-3 fatty acids on insulin resistance, insulin sensitivity,…