Study of Tamoxifen and Raloxifene (STAR)
The Study of Tamoxifen and Raloxifene, or STAR, is a clinical trial that began at an estimated 500 sites across the United States and Canada early in 1999. Participants in STAR include approximately 19,000 postmenopausal women who are at increased risk for breast cancer. They have received a drug that could reduce their chances of developing breast cancer.
STAR builds upon the success of the Breast Cancer Prevention Trial (BCPT), which showed that high-risk women taking the drug tamoxifen for an average of four years had a 49 percent reduced chance of developing breast cancer.
STAR will determine whether raloxifene (Evista®), a drug similar to tamoxifen, is also effective in reducing the chance of developing breast cancer in women who have not had the disease, and whether the drug has benefits over tamoxifen (Nolvadex®), such as fewer side effects. Raloxifene was approved by the FDA (Food and Drug Administration) as an osteoporosis prevention drug for postmenopausal women.
Women chosen to participate in STAR are age 35 or older, are postmenopausal, and have an increased risk of breast cancer as determined by their: age, family history of breast cancer, personal medical history, age at first menstrual period, and age at first live birth. They have been randomly assigned to receive either tamoxifen daily or raloxifene daily for five years. They will receive close follow-up examinations, including mammograms, physical examinations, and gynecologic examinations, on a regular basis for at least 7 years.
The National Surgical Adjuvant Breast and Bowel Project (NSABP), which conducts the trial, selected the 193 main institutions to participate in STAR, including sites in 48 states, six Canadian provinces, the District of Columbia, and Puerto Rico. These 193 institutions have formed networks with other local physicians, creating an estimated 400 active centers participating in the trial.
STAR began enrolling participants in 1999. As of June, 2005, the study had reached its enrollment goal. The study is closed to new participants, and results are expected in 2006.
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