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Randomized clinical trials of raloxifene: reducing the risk of osteoporosis and breast cancer in postmenopausal women

Olevsky, Olga M. MD; Martino, Silvana DO

doi: 10.1097/gme.0b013e31817e6683

The P-1 trial of tamoxifen versus placebo for breast cancer prevention in high-risk women provided proof of the concept that chemoprevention was effective. The approval of tamoxifen for this indication in 1998 provided a pharmaceutical agent as an alternative to bilateral mastectomy and/or oophorectomy for women at high risk. Although for some women and their physicians this was a welcome alternative, fear of toxicities from tamoxifen has been a major barrier to its use. Four trials evaluating the role of raloxifene in breast cancer prevention have resulted in the recent approval by the US Food and Drug Administration for postmenopausal women with osteoporosis or at high risk of breast cancer. It has a more favorable toxicity profile than tamoxifen and provides an alternative for postmenopausal women.

This article summarizes data leading to the approval of raloxifene as therapy for the prevention of invasive breast cancer in postmenopausal women with either osteoporosis or at high risk for breast cancer.

From The Angeles Clinic and Research Institute, Santa Monica, CA.

Received December 31, 2007; revised and accepted April 29, 2008.

Financial disclosure: Dr. Olga Olevsky has no conflict of interest to report. Dr. Silvana Martino has served as a principal investigator to the Continuing Outcomes Relevant to Evista (CORE) trial. She has provided consulting services to Eli Lilly during analysis and presentation of the CORE data and in the preparation to present the raloxifene data to the Oncologic Drugs Advisory Committee.

Address correspondence to: Silvana Martino, DO, The Angeles Clinic and Research Institute, 2001 Santa Monica Boulevard, Suite 560W, Santa Monica, California 90404. E-mail:

©2008The North American Menopause Society