drugset / Trial / NCT00917735

Green Tea and Reduction of Breast Cancer Risk

NCT00917735

RandomizedParallel-groupQuadruple-blindPrevention

Summary

RATIONALE: Green tea extract contains ingredients (catechins) that may lower the risk of breast cancer. PURPOSE: This phase II trial is studying how well green tea extract works in preventing breast cancer compared to a placebo in postmenopausal women with high breast density. The investigators have hypothesized that green tea consumption reduces breast cancer risk, and this effect is seen primarily in women who have the low-activity COMT genotype. The investigators will test this by evaluating the effects of green tea extract on breast cancer biomarkers including mammographic density, plasma insulin-like growth factor 1 (IGF-1), IGF binding protein 3 (IGFBP-3), estrone, estradiol, androstenedione, sex hormone binding globulin (SHBG), urinary estrogen metabolites and plasma F2-isoprostanes.

Timeline

Start
2009-07
Primary completion
2014-06
Completion
2014-06

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject green tea extract Unknown 800 mg Oral

Indications