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The STAR Trial: Raloxifene Proves Effective in Preventing Breast Cancer

Preliminary results from the National Cancer Institute (NCI) STAR Trial, the Study of Tamoxifen and Raloxifene, show that raloxifene works as well as tamoxifen to prevent breast cancer in post-menopausal women at increased risk for the disease — with fewer side effects.

The STAR Trail is one of the largest breast cancer prevention studies ever assembled. More than 500 medical centers enrolled nearly 20,000 participants in the study. It compared the breast cancer prevention potential of tamoxifen, used as a treatment for breast cancer and the first approved breast cancer chemopreventive, and raloxifene, a drug given to post-menopausal women to help prevent osteoporosis.

Begun in 1999, the STAR Trial has been charged with determining whether raloxifene is more or less effective than tamoxifen in reducing the incidence rate of invasive breast cancer in postmenopausal women. Results show a 50 percent reduction of risk for developing invasive breast cancer -- with 36 percent fewer cases of uterine cancer, a serious side effect of tamoxifen.

The trial enrolled 19,747 postmenopausal women at increased risk of breast cancer due to age, family history of breast cancer, personal medical history, age at first menstrual period and age when she first gave birth. Participants were randomly assigned to receive either 20 mg tamoxifen or 60 mg raloxifene daily for five years. Each participant was provided regular follow-up examinations, including mammograms and gynecologic exams.

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