A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF 4-HYDROXYTAMOXIFEN TOPICAL GEL IN WOMEN WITH MAMMOGRAPHICALLY DENSE BREASTS

University Of Tx Md Anderson Can Ctr, Houston TX

Investigators

Abstract

The goal of this solicitation is to develop, conduct and analyze a randomized three-arm breast cancer prevention study among women age 40-50 years of age or <40 years if Gail risk ?1.66 (including BRCA1/2 mutation carriers) with mammographically dense breasts (BIRADS C or D, according to fifth edition classification) to assess whether daily application of 2 mL or 4 mL of afimoxifene (4-hydroxytamoxifen) gel lowers breast density.