May 25, 1999
The planned seven-year international Study of Tamoxifen and Raloxifene (STAR) will recruit 22,000 postmenopausal women 35 and older considered at increased risk for the disease by the study's sponsor, the National Surgical and Adjuvant Breast and Bowl Project (NSABP). "There is no better way to attack this cancer than to prevent it in the first place, and these two drugs already have demonstrated significant potential to do just that," says Martin D. Abeloff, M.D., director of the Johns Hopkins Oncology Center.
Funded by the National Cancer Institute, Eli Lilly and Company and Zeneca Pharmaceuticals, the Hopkins STAR study will begin enrolling qualified volunteers pending final approval of the trial by Hopkins's institutional review board.
Both drugs, tamoxifen and raloxifene, known scientifically as selective estrogen receptor modulators, work by blocking estrogen uptake by breast tissue. Estrogen, a female hormone, can promote the growth of breast cancer. The cancer-prevention properties of tamoxifen were shown last year in another NSABP study, which found a 49 percent decrease in the incidence of invasive breast cancer in high-risk women who took it. The Food and Drug Administration (FDA) then approved its use for women who are at high-risk for this disease. Tamoxifen, however, does produce side effects, which Raloxifene may not. Approved by the FDA for treatment of osteoporosis, Raloxifene appears to be useful in preventing breast cancer because of the decreased incidence of the disease observed in over 10,000 postmenopausal women taking the drug as therapy for the bone disease. The STAR trial will not only be the first breast cancer prevention trial for Raloxifene, but will also compare the effectiveness of both drugs.
Eligible study participants include postmenopausal women 35 and older at an increased risk for developing breast cancer determined by factors such as family history for the disease and personal medical history. They will be randomly chosen to take daily doses of either tamoxifen or raloxifene for five years and closely followed for seven years through physical and gynecologic exams, mammograms, and personal and telephone interviews by a STAR Trial physician or nurse practitioner. Data from the study will allow experts to compare the drugs, their side effects, and evaluate their overall ability to reduce the chance of developing breast cancer.
STAR trial centers, like the one at Hopkins, will be located throughout most of the United States as well as Canada and Puerto Rico. "This landmark trial will give many women across the nation a chance to help answer our questions about these two drugs and make them accessible to women seeking a potential breast cancer prevention option," says Kathy Helzlsouer, M.D., M.H.S., principal investigator and associate professor of epidemiology and oncology at Johns Hopkins.
Both drugs will be provided at no cost to women participating in the study. Individuals interested in participating in the STAR trial may call the Johns Hopkins Oncology Center STAR Trial coordinator at 410-614-STAR (7827).
Note: The NSABP and the NCI has footage and B-roll available to reporters, editors and producers from a press conference held today, May 25, 1999 at the National Press Club in Washington, D.C.
Related Web Sites:
Johns Hopkins STAR information: http://www.med.jhu.edu/breastcenter/research/star.html
The National Surgical Adjuvant Breast and Bowel Project (NSABP): http://www.nsabp.pitt.edu
The National Cancer Institute (NCI) Clinical Trials: http://cancertrials.nci.nih.gov