Name of the Trial
Phase III Randomized Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer (NSABP-P-2). See the protocol summary at http://cancer.gov/clinicaltrials/NSABP-P-2.
Dr. Norman Wolmark, chairman, National Surgical Adjuvant Breast and Bowel Project (NSABP)
Why Is This Trial Important?
In 1998, results from the Breast Cancer Prevention Trial showed that tamoxifen (brand name Nolvadex®) reduced the chance of developing breast cancer by about half in premenopausal and postmenopausal women at increased risk of breast cancer. Large studies testing the effectiveness of raloxifene (brand name Evista®) against osteoporosis have shown that the drug reduces the incidence of breast cancer in postmenopausal women with a history of osteoporosis.
STAR will determine whether the osteoporosis prevention drug raloxifene is as effective as the cancer prevention drug tamoxifen in reducing the chance of developing breast cancer in postmenopausal women.
"Another important part of STAR will be to assess the long-term safety of raloxifene versus tamoxifen in women at increased risk of breast cancer," said Dr. Wolmark of NSABP, the group of researchers conducting the trial. "The two drugs have different side effects, which we need to better understand."
Who Can Join This Trial?
STAR will include 19,000 postmenopausal women age 35 and older who are at high risk for developing breast cancer. More than 17,500 have already joined the trial since it opened in 1999. See the full list of eligibility criteria for this trial at http://cancer.gov/clinicaltrials/NSABP-P-2.
Where Is This Trial Taking Place?
More than 500 sites in the United States, Puerto Rico, and Canada are enrolling participants in STAR. See the list of study sites at http://cancer.gov/clinicaltrials/NSABP-P-2.
Who to Contact
See the list of study contacts at http://cancer.gov/clinicaltrials/NSABP-P-2 or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll-free and completely confidential. Information is also available at NSABP's Web site about breast cancer prevention or NSABP's Web page about STAR.