Abstract

On 13 September 2007, raloxifene was approved by the US FDA for reducing the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer and in women with osteoporosis. This approval was the result of the findings from the Multiple Outcomes of Raloxifene Evaluation (MORE) trial and the Study of Tamoxifen And Raloxifene (STAR). MORE, an osteoporosis treatment trial, suggested that raloxifene reduced the incidence of breast cancer in average-risk postmenopausal women with osteoporosis. STAR compared the proven preventive agent tamoxifen with raloxifene, a selective estrogen receptor modulator that had been suggested to have a preventive benefit with fewer side effects. The results of STAR showed that raloxifene is equivalent to tamoxifen in the prevention of invasive breast cancer. Postmenopausal women now have a second option to reduce their risk of invasive breast cancer.

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