Study of Tamoxifen and Raloxifene to Open in Early 1999 at Johns Hopkins

The Study of Tamoxifen and Raloxifene (STAR) is set to open at an estimated 400 sites across the United States and Canada in early 1999. The Johns Hopkins Breast and Ovarian Surveillance Service (BOSS) lead by Dr. Kathy Helzlsouer will be a site for this trial. The study will recruit 22,000 postmenopausal women at increased risk of breast cancer and give them a drug that could reduce their chance of developing breast cancer.

STAR builds upon the success of the Breast Cancer Prevention Trial (BCPT), the first large-scale breast cancer prevention study in North America. BCPT showed that high-risk women taking the drug tamoxifen (Nolvadex®) for an average of four years reduced their chance of developing breast cancer by 49 percent. Tamoxifen also reduced the number of bone fractures of the hip, wrist, and spine. However, the drug did increase the women's chances of three less common but very concerning health problems, endometrial cancer (cancer of the lining of the uterus), deep vein thrombosis (blood clots in a large vein), and pulmonary embolism (blood clot in the lung).

STAR will determine whether raloxifene (Evista®), a drug similar to tamoxifen, is also effective in reducing the chance of developing breast cancer and whether the drug has benefits over tamoxifen, such as fewer side effects. Raloxifene was recently approved by the FDA as an osteoporosis prevention drug for postmenopausal women. To be eligible for the study, women must be age 35 or older, postmenopausal, and have an increased risk of breast cancer as determined by their age, family history of breast cancer, personal medical history, age at first menstrual period, and age at first live birth. They will be randomly assigned to receive either 20mg of tamoxifen daily or 60mg of raloxifene daily for five years. They will be closely followed for at least seven years.

The National Surgical Adjuvant Breast and Bowel Project (NSABP), a National Cancer Institute sponsored research network based in Pittsburgh, PA will run the trial. NSABP has selected the institutions that will participate in STAR, including sites in 48 states, six Canadian provinces, District of Columbia, and Puerto Rico. These institutions will form networks with other local physicians, creating an estimated 400 active centers participating in the trial.

Women who wish to be put on a mailing list for information about STAR can do so by contacting NSABP:

NSABP

Box 21

Pittsburgh, PA 15261

Internet: www.nsabp.pitt.edu

Fax: (412) 330-4660

Once the trial has begun, information can be obtained by calling NCI's Cancer Information Service at 1-800-4-CANCER (422-6237) or by visiting NCI's web site for clinical trials at cancertrials.nci.nih.gov.

For more information about the STAR Trial, please contact Jennifer Bucholtz, Nurse Practitioner and Study Coordinator for STAR at the Johns Hopkins Breast Center, at (410) 614-STAR (7827).