The future of women of minority race/ethnicity in breast cancer chemoprevention therapy.

Women of minority race/ethnicity have been underrepresented in United States-based breast cancer chemoprevention trials. Searches of Medline between 1966 and 2004 were done with priority given to recent reports (1996-2004), and references from bibliographies of relevant articles. Large chemoprevention trials have reported significant breast cancer risk reduction and increased risk of serious adverse events in tamoxifen-treated, high-risk women, which illustrates the need to carefully assess the risk/benefits of this therapy. The mathematical model used for this purpose in the United States-based trials has resulted in the inclusion of very few women of minority racial/ethnic backgrounds. The continued use of this risk assessment that has not been adequately validated for its usefulness in non-Caucasian populations, should be reviewed, especially given that adequate alternative nonmathematical models exist. Current and future chemoprevention trials should also use nonmathematical selection criteria to ensure that eligible underrepresented minorities are adequately included in these trials.