Nationally, study organizers plan to enroll 22,000 women among participating sites. So far, 14,369 women are participating in STAR--about 65 percent of the goal. Studywide, 851 minority women have enrolled, about 6 percent of all participants. A total of 129,990 women have completed risk assessment forms.
"Tamoxifen is a medically proven intervention, but it does have drawbacks," Dr. Bevers says. "Women at an increased risk need breast cancer prevention options with a minimum of side effects, and STAR is a concerted effort to find one."
STAR is a follow-up to the landmark Breast Cancer Prevention Trial (BCPT), which yielded the finding that tamoxifen reduced breast cancer risk by 49 percent in women at high risk for developing the disease. Because of BCPT findings, the U.S. Food and Drug Administration in October 1998 approved tamoxifen to prevent breast cancer in high-risk women. Tamoxifen has been used for more than two decades to treat breast cancer.
"Until the FDA approved tamoxifen, high-risk women had no other option but to participate in vigilant screening to detect breast cancer in the earliest stages," Dr. Bevers says. "It was a matter of waiting until the disease developed, then treating the cancer."
M. D. Anderson's satellite sites include St. Luke's Episcopal Hospital in Houston, Memorial Health System of East Texas/Arthur Temple Sr. Regional Cancer Center in Lufkin, Providence Memorial Hospital in El Paso, The University of Texas Health Center in Tyler, Christus Shumpert Health System in Shreveport, La., and M. D. Anderson Cancer Center in Orlando, Fla.
Women who participate in STAR must be postmenopausal, at least age 35 and have an increased risk of breast cancer as determined by
Contact: Alison Ruffin
University of Texas M. D. Anderson Cancer Center