Soy and Tamoxifen for Breast Cancer Prevention in High Risk Pre-Menopausal Women
Final rept. 17 Sep 2001-16 Sep 2004
CALIFORNIA UNIV SAN FRANCISCO
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The current study is testing 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. One hundred women will be randomized to either 25 gday of soy protein or placebo milk protein. The randomized placebo controlled design will allow for comparative toxicity and efficacy determinations using patient symptom scores and validated quality of life tools. Biological endpoints, including mammographic breast density, breast cytology, urinary estrogen metabolites, and blood serum biomarkers IGF-1IGF-BP 3, will be evaluated. 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. Presently, 25 women have completed the study protocol and 24 women are on study treatment with the last women being scheduled to complete the study in January of 2005.
- Medicine and Medical Research
- Food, Food Service and Nutrition