December 18, 1998

The MGH is participating in a major national study of breast cancer prevention. The study, coordinated in this region by the Dana-Farber Cancer Institute, will compare the ability of two drugs – tamoxifen and raloxifene – to prevent breast cancer in healthy women at high risk for the disease. Dubbed the STAR trial, for "Study of Tamoxifen and Raloxifene," the study seeks to enroll 22,000 postmenopausal women over the next five years at 193 "core" sites across the United States, Canada and Puerto Rico.

The trial comes as a follow-up to a study that recently found regular use of tamoxifen reduced breast cancer rates by nearly 50 percent in women at risk for the disease. Like that study, the new trial is being organized by the Pittsburgh-based National Surgical Adjuvant Breast and Bowel Project, with support from the National Cancer Institute.

Raloxifene is a drug that is chemically similar to tamoxifen and has received Food and Drug Administration approval for use against osteoporosis. In the osteoporosis study, it decreased the risk of breast cancer as well. Both tamoxifen and raloxifene have side effects, including blood clots and endometrial cancer, so study participants must be considered carefully.

To be eligible for the study, women must be postmenopausal and have no personal history of breast cancer. They must, however, be at increased risk for breast cancer based on a consideration of their family history and other risk factors. The women participating in the study will be assigned randomly to take either tamoxifen or raloxifene every day for five years (they won't be told which drug they're taking). They will receive medical follow-up, including mammogram and gynecological exams, for seven years to assess the benefits (whether breast cancer incidence is decreased) and risks (rate of side effects).

The principal investigator for the study at the MGH is Barbara Smith, MD, PhD, of the MGH Gillette Center for Women's Cancers. BWH and 12 other New England-area hospitals and health centers are participating with Dana-Farber in the study.

The trial is scheduled to begin early in 1999. For more information about the study or to enroll, call 4-4800.