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The effects of raloxifene on mammographic breast density: a review of clinical trials

Pearman, Leny MS, CNS1; Kagan, Risa MD, FACOG, CCD, NCMP2; Arsenault, Jody PhD1; Muram, David MD1

doi: 10.1097/gme.0b013e3181c29e56
Review Articles

Objective: Breast density is an independent risk factor for the development of invasive breast cancer (BC). It has been hypothesized that because raloxifene (RLX) has been shown to reduce BC risk, its use will result in reduced breast density.

Methods: This article provides a review of seven clinical studies that examined the effects of RLX on breast density.

Results: Overall, RLX did not increase or decrease mammographic breast density. This article provides a review of the various methods used to determine breast density in these RLX studies and offers a potential explanation as to why the studies failed to show an effect on mammographic density.

Conclusions: Presently, no clinical recommendations can be made with regard to RLX and its effects on breast density. To determine the effect of RLX on breast density, larger studies need to be conducted in postmenopausal women with high breast density at baseline who are at high risk for BC, with a standardized method of breast density measurement.

Overall, raloxifene did not increase or decrease mammographic breast density. At this time, no clinical recommendations can be made with regard to raloxifene and its effects on breast density.

Received June 30, 2009; revised and accepted September 22, 2009.

From the 1Lilly USA, LLC, Indianapolis, IN; and 2East Bay Physicians Medical Group, University of California, San Francisco, San Francisco, CA.

Funding/support: Funding was provided by Lilly USA, LLC.

Financial disclosure/conflict of interest: J. Arsenault, D. Muram, and L. Pearman are full-time employees and stockholders of Lilly USA, LLC. Dr. Risa Kagan is on the editorial board of the Journal Menopause and the Board of Trustees for The North American Menopause Society. Dr. Risa Kagan received consulting fees and was an ad board member for Wyeth, P&G/Aventis, Lilly, Depomed, Medtronic, and FORE and received speaker's honoraria from Lilly, Novartis, Novogyne, and GlaxoSmithKline. Dr. Risa Kagan has received research support from Lilly, Depomed, Boehinger-Ingelheim, Novartis, and P&G. Dr. Risa Kagan's spouse, Dr. Richard Stern, has received research support and is a consultant for Medtronic.

Address correspondence to: Leny Pearman, MS, CNS, Lilly USA, LLC, Lilly Corporate Center, Drop Code 4109, Indianapolis, IN 46285. E-mail:

©2010The North American Menopause Society