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. Currently 14 women have been randomized and 7 more are scheduled to attend screening or randomization clinic visits in the next two months.

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Document Details

Document Type
Technical Report
Publication Date
Oct 01, 2003
Accession Number
ADA420239

Entities

People

  • Jeffrey A. Tice

Organizations

  • University of California, San Francisco

Tags

DTIC Thesaurus Topics

  • Abstracts
  • Alkenes
  • Biomedical Research
  • Breast Cancer
  • California
  • Classification
  • Electronic Mail
  • Information Operations
  • Job Analysis
  • Maryland
  • Monitoring
  • Neoplasms
  • Personnel Management
  • Quality Of Life
  • Security
  • Universities

Fields of Study

  • Medicine

Readers

  • Clinical Trial Research.
  • Women's Health and Cancer Risk Research: African American Women and Pregnancy Outcomes.