Soy and Tamoxifen for Breast Cancer Prevention in High Risk Pre-Menopausal Women
Final addendum 17 Sep 2004-16 Sep 2005
CALIFORNIA UNIV SAN FRANCISCO
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We conducted a feasibility study to assess the efficacy and safety of dietary soy for breast cancer prevention in pre-menopausal women at elevated risk of breast cancer. Mammographic breast density, a potential surrogate marker for breast cancer risk, was used as the primary entry criterion and the primary outcome. 47 pre-menopausal women with breast density 50 on mammography were randomized to either 25 mgld of soy protein containing 50 mg total isoflavones or 25 mglday of milk protein containing 0 mg of total isoflavones for 6 months. At randomization, the average 5-year Gail risk was 2.0 and the average breast density was 73 range 59-90. The average change in percentage breast density was -2.7 in the soy arm and -2.4 in the placebo arm pO.48. There were no differences between groups in the change in lGF-I or lGFBP3. The results of this study do not support the hypothesis that 6 months of soy protein reduces the risk of breast cancer in pre-menopausal women. However, the intervention was relatively short and the primary outcomes were surrogate markers of risk.
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