STAR Trial for the Prevention of Breast Cancer
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.
Dr. Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project.
Why This Trial Is 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," says Norman Wolmark, MD, chairman of the National Surgical Adjuvant Breast and Bowel Project (NSABP). NSABP is conducting the trial, and Wolmark is the trial's principal investigator. "The two drugs have different side effects, which we need to better understand."
This trial is closed to further patient recruitment. To find other breast cancer clinical trials, search the NCI's database of clinical trials or call the National Cancer Institute's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll-free and completely confidential.
Ganz PA, Land SR, Wickerham DL, et al.: The study of tamoxifen and raloxifene (STAR): first report of patient-reported outcomes (PROs) from the NSABP P-2 breast cancer prevention study. [Abstract] J Clin Oncol 24 (Suppl 18): A-LBA561, 2006.
Land SR, Wickerham DL, Costantino JP, et al.: Patient-Reported Symptoms and Quality of Life During Treatment With Tamoxifen or Raloxifene for Breast Cancer Prevention: The NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 Trial. JAMA 295:2742-2751, 2006.[PUBMED Abstract]
Vogel VG, Costantino JP, Wickerham DL, et al.: Effects of Tamoxifen vs Raloxifene on the Risk of Developing Invasive Breast Cancer and Other Disease Outcomes: The NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 Trial. JAMA 295:2727-2741, 2006.[PUBMED Abstract]
Gradishar WJ, Cella D: Selective Estrogen Receptor Modulators and Prevention of Invasive Breast Cancer. JAMA 295:2784-2786, 2006.[PUBMED Abstract]