Soy and Tamoxifen for Breast Cancer Prevention in High Risk Pre-Menopausal Women
Annual rept. 17 Sep 2001-16 Sep 2002
CALIFORNIA UNIV SAN FRANCISCO
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The current study will test the feasibility and preliminary efficacy of soy supplementation to decrease risk of breast cancer by reducing breast density in individuals with 50 breast density on mammography and who are at elevated risk for breast cancer. Tamoxifen, the only prophylactic agent known to be effective for breast cancer, will be used as a positive control to validate the use of the proposed surrogate markers including breast density. A randomized placebo controlled design will allow for comparative toxicity and efficacy determinations using patients symptoms scores and validated quality of life tools. Biological endpoints of mammographic breast density, breast cytology, urinary estrogen metabolites, and blood serum biomarkers IGF-1IGF-BP 3 will be validated using tamoxifen compared with placebo. The magnitude of the soy effect on the same markers will then be compared with that of tamoxifen. Feasibility will be assessed by measuring the rate of recruitment, the percentage of women consuming at least 80 of the expected number of protein packets, and the dropout rate. Initial participant screening has just begun and clinic visits are expected to start in October 2002. At this date there is no data or results to report.
- Medicine and Medical Research