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University of Cincinnati Academic Health Center
Publish Date: 05/25/99
Media Contact: AHC Public Relations, (513) 558-4553
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University of Cincinnati Medical Center Announces Participation in Major Breast Cancer Prevention Trial

Cincinnati—The study of tamoxifen and raloxifene (STAR), one of the largest breast cancer prevention studies ever, is now recruiting volunteers at more than 400 centers across the United States, Canada, and Puerto Rico, including the University of Cincinnati (UC). "We are excited about being able to offer Greater Cincinnati women the chance to participate in this important study," says Elizabeth Shaughnessy, MD, PhD, principal investigator for the Greater Cincinnati site at The University Hospital Barrett Cancer Center and assistant professor of surgery at the UC College of Medicine.

The trial will include 22,000 postmenopausal women at increased risk of breast cancer to determine whether the osteoporosis prevention drug raloxifene (Evista) is as effective in reducing the chance of developing breast cancer as tamoxifen (Nolvadex). The study is being conducted through the National Surgical Adjuvant Breast and Bowel project (NSABP), which is a National Cancer Institute (NCI) supported network of researchers. According to NSABP chairman Norman Wolmark, MD, "Studies of raloxifene suggest it has the potential to prevent breast cancer. The only way to prove that potential is to do a clinical trial in which the risks and benefits of raloxifene are directly compared with the risks and benefits of tamoxifen."

Tamoxifen proved to reduce the chance of developing breast cancer by about 50 percent in the Breast Cancer Prevention Trial (BCPT), a study of over 13,000 premenopausal and postmenopausal women at high risk of breast cancer. Results of the BCPT were announced a year ago and published in the Journal of the National Cancer Institute in September 16, 1998. In the BCPT, half of the women took tamoxifen and half took a placebo. Those given tamoxifen also had fewer fractures of the hip, wrist, and spine than women taking the placebo. However, researchers also documented that tamoxifen increased a womanÕs chances of developing four potentially life-threatening health problems: endometrial cancer (cancer of the lining of the uterus), deep-vein thrombosis (blood clots in large veins), pulmonary embolism (blood clot in the lung), and stroke. Last October, the US Food and Drug Administration (FDA) approved the use of tamoxifen to reduce the incidence of breast cancer in women at an increased risk.

Raloxifene was approved by the FDA in December 1997 to prevent osteoporosis. The risks of developing pulmonary embolism or blood clots in the larger veins while taking raloxifene are similar to the risks associated with tamoxifen, but the risk of developing endometrial cancer did not increase with the use of raloxifene. STAR researchers will ultimately compare the long-term safety of both drugs in women at increased risk of breast cancer.

Leslie Ford, MD, associate director for clinical research in the NCI's Division of Cancer Prevention, says "Tamoxifen is a medically proven intervention, but it is not perfect." Women need breast cancer prevention options with a minimum of side effects. STAR is a concentrated effort to find one.

Participants in STAR must be at least 35 years old and have an increased risk of breast cancer as determined by age, family history, personal medical history, age at first menstrual period, and age at first live birth. Once a woman chooses to participate, she will be randomly assigned to receive either 20 mg of tamoxifen or 60 mg of raloxifene daily for five years and will have regular examinations, mammograms, and gynecologic tests. The University of Cincinnati site will be coordinating with the following local hospitals for recruitment of women into the study: Middletown Regional Hospital, TriHealth (Good Samaritan/Bethesda Hospitals), The St. Luke Hospitals, The Christ Hospital, The Jewish Hospital, and THe University Hospital.

The maker of tamoxifen, Zeneca Pharmaceuticals, and the maker of raloxifene, Eli Lilly and Company, are providing their drugs for the trial free of charge. Eli Lilly and Company has also given the NSABP a $36 million grant to defray recruitment costs at the participating centers and to help local investigators conduct the study. For more information about STAR, call the UC Medical Center at (513) 584-2278 or visit the NSABP Web site at http://www.nsabp.pitt.edu or the NCI clinical trials web site at http://cancertrials.nci.nih.gov.



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