Soy and Tamoxifen for Breast Cancer Prevention in High Risk Pre-Menopausal Women
Abstract
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 g/day 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-1/IGF-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.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2004
- Accession Number
- ADA429929
Entities
People
- Jeffrey A. Tice
Organizations
- University of California, San Francisco