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University of Iowa News Release

March 25, 2004

Breast Cancer Prevention Researchers Make Final Enrollment Push

University of Iowa Health Care researchers say their goal of helping to enroll 19,000 women in the largest breast cancer prevention trial in North American history is within reach.

Nearly 18,000 women already have agreed to participate in the Study of Tamoxifen and Raloxifene (STAR). One thousand more women still are needed nationwide to help complete this important study. UI Hospitals and Clinics and its satellite clinics have enrolled 185 participants and will continue to actively recruit until the final 1,000 have been accrued.

Researchers predict that women will have results by 2006, and will then know which drug, tamoxifen or raloxifene, does a better job of preventing breast cancer while causing fewer side effects. More than 500 sites in the United States, Canada and Mexico are participating in STAR, which began enrolling women in 1999.

STAR is the follow-up to the landmark Breast Cancer Prevention Trial that led to the approval of tamoxifen in 1998 by the U.S. Food and Drug Administration for reducing the risk of breast cancer among women with an increased risk for developing the disease.

If a woman chooses to participate in STAR, she is randomly assigned to take daily either 20 milligrams of tamoxifen or 60 milligrams of raloxifene. Participants also receive regular examinations until the results of the trial are known.

"The health of the women in STAR is our top priority because they face an increased risk for breast cancer," said Mary Fitzgerald, assistant nurse manager, who coordinates the study at UI Hospitals and Clinics. "As part of the trial, we monitor their health very closely."

STAR includes postmenopausal women who have an increased risk for breast cancer due to family history and a combination of personal medical factors. The researchers use these factors to estimate a woman's individual risk for developing the disease within the next five years and in her lifetime.

The National Surgical Adjuvant Breast and Bowel Project, a not-for-profit cancer research group, oversees STAR. The National Cancer Institute (NCI) is funding the study. For more information about STAR, or to locate a STAR center in the U.S. and Puerto Rico, contact the NCI's Cancer Information Service at 1-8004-CANCER (1-800-422-6237). The Cancer Information Service in the Holden Comprehensive Cancer Center at the UI can also provide information about STAR at 1-800-237-1225.

As an alternative, visit online at www.breastcancerprevention.com to calculate your risk for breast cancer or to find more information about STAR.

Holden Comprehensive Cancer Center is Iowa's only NCI-designated comprehensive cancer center. NCI-designated comprehensive cancer centers are recognized as the leaders in developing new approaches to cancer prevention and cancer care, conducting leading edge research and educating the public about cancer.

University of Iowa Health Care describes the partnership between the UI Roy J. and Lucille A. Carver College of Medicine and UI Hospitals and Clinics and the patient care, medical education and research programs and services they provide. Visit UI Health Care online at http://www.uihealthcare.com.

STORY SOURCE: Joint Office for Marketing and Communications, University of Iowa Health Care, 200 Hawkins Drive, Room E110 GH, Iowa City, Iowa 52242-1009

MEDIA CONTACT: Tom Moore, 319-356-3945, thomas-moore@uiowa.edu.