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University of Cincinnati Academic Health Center
Publish Date: 08/14/00
Media Contact: AHC Public Relations, (513) 558-4553
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Academic Health Center Seeks Women for Breast Cancer Prevention Study

Cincinnati--The UC Medical Center is seeking women to participate in the continuing study of the breast cancer prevention drugs, tamoxifen and raloxifene. UC is among 500 centers across the United States, Puerto Rico and Canada who are enrolling participants in this landmark prevention study called STAR (Study of Tamoxifen And Raloxifene).

STAR is a study of the National Surgical Adjuvant Breast and Bowel Project (NSABP) supported by the National Cancer Institute (NCI) designed to determine whether raloxifene (Evista®) is as effective as tamoxifen (Nolvadex®) in reducing breast cancer risk. Now in its second year, STAR has enrolled 6,139 postmenopausal women nationwide who have an increased risk of breast cancer. In addition, more than 47,000 women have received individualized, no-obligation assessments to determine their risk of breast cancer and to weigh the pros and cons of joining the trial since enrollment began.

"More than 250 women from Ohio are already participating in STAR, including 26 women in the Greater Cincinnati Collaborative Prevention Trial Group," says Elizabeth Shaughnessy, MD, PhD, assistant professor, UC Department of Surgery. "This trial has a 5-year recruitment plan, but we hope to accomplish this goal within the next two to three years. All eligible women who live in the Greater Cincinnati/Northern Kentucky area are encouraged to participate."

Participants in STAR must be postmenopausal, at least age 35, and have an increased risk of breast cancer as determined by their age, family history of breast cancer, personal medical history, and age at first menstrual period. They will also go through a process known as informed consent, during which they will learn about the potential benefits and risks of tamoxifen and raloxifene before deciding to participate in STAR.

Tamoxifen has been proven to reduce breast cancer incidence by 49 percent in women with increased risk. The Food and Drug Administration (FDA) approved the use of tamoxifen to reduce the incidence of breast cancer in women with an increased risk of the disease in October 1998. Tamoxifen has been approved by the FDA to treat women with breast cancer for more than 20 years. Tamoxifen was approved by the FDA following the Breast Cancer Prevention Trial (BCPT), which proved that tamoxifen reduced breast cancer in high-risk women who had not yet had breast cancer.

Raloxifene was shown to reduce the incidence of breast cancer during a large study of its use to prevent and treat osteoporosis. This drug was approved by the FDA to prevent osteoporosis in postmenopausal women in December 1997 and to treat osteoporosis in postmenopausal women in September 1999.

Both tamoxifen and raloxifene may increase a woman's risk of developing rare but potentially life-threatening health problems such as blood clots in deep veins and/or the lungs. Tamoxifen use may also increase a woman's risk of stroke and endometrial cancer at a rate similar to estrogen replacement therapy. More than half of the women enrolled in STAR had a hysterectomy prior to enrollment and are not at risk for endometrial cancer.

Postmenopausal women in the Greater Cincinnati/Northern Kentucky area who are interested in participating in STAR can call the University of Cincinnati at (513) 584-2278 or visit the NSABP website at http://cancertrials.nci.nih.gov. For more information call the NCI Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The number for callers with TTY equipment is 1-800-332-8615.

Evista and evista.com are registered trademarks of Eli Lilly and Company.Nolvadex is a registered trademark of Zeneca Pharmaceuticals.



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