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Results of STAR Trial may help prevent breast cancer

Baptist Health Louisville was one of over 400 trial sites in the United States, Canada and Puerto Rico for the Study of Tamoxifen and Raloxifene (STAR), which began enrolling participants in early 1999.

The five year study, conducted by the NSABP, compared the effects of tamoxifen, a drug shown in previous clinical trials to reduce the incidence of breast cancer, and raloxifene, a drug that may have similar results with a potential for fewer side effects.

Baptist Health Louisville participated in the first trial, which showed tamoxifen reduced breast cancer incidence in women who took the drug by 49 percent.

Tamoxifen is currently the most widely prescribed anti-cancer drug in the world. It was effective in preventing breast cancer in high-risk women in the first trial, but resulted in some rare, serious side effects such as an increased risk of endometrial cancer, pulmonary embolism and deep vein thrombosis.

The study examined whether raloxifene was also effective in preventing invasive breast cancer in women who have not had the disease and whether it offers any benefits over results obtained with tamoxifen.

Raloxifene has been approved by the Food and Drug Administration for the prevention of osteoporosis and preliminary data shows that it may have similar preventative benefits for breast cancer, with fewer side effects.

Up to 22,000 postmenopausal women in North America, age 35 and older who were considered at increased risk for breast cancer, were enrolled in the study.

Risk assessment questionnaires were used to determine who was eligible to participate in the study.

Participants were randomly assigned to receive either 20 mg of tamoxifen or 60 mg of raloxifene for five years. Follow-up examinations, including a mammogram, physical exam and gynecologic exam, were given on a regular basis for at least seven years.

Principal investigator for the study is Daniel C. Scullin Jr., MD, of the oncology group Consultants in Blood Disorders and Cancer. Other members of the practice involved in the trial were Charles E. Dobbs, MD; Michael D. Kommor, MD; Manuel Grimaldi, MD; Charles Dannaher, MD; Charles Webb, MD; Geetha Joseph, MD; Ignacio Montes, MD; and Judy Sisk, RN, ONC.

For more information about this and other clinical trials, call Baptist Health Louisville at (502) 897-8131.