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University of Iowa News Release

Sept. 10, 2004

Breast Cancer Prevention Researchers Attain Recruitment Goal Early

Researchers at University of Iowa Hospitals and Clinics reported today that they have reached their goal of helping to enroll 19,000 women in the largest breast cancer prevention trial in North American history a month ahead of schedule.

The Study of Tamoxifen and Raloxifene (STAR) will allow women who are still being evaluated for the study to continue to join the trial until October 2004. Researchers from the National Adjuvant Breast and Bowel Project (NSABP) predict that women will know which drug, tamoxifen (Nolvadex) or raloxifene (Evista), is more effective in preventing breast cancer with fewer side effects by the summer of 2006. More than 500 sites in the United States, Canada and Puerto Rico are involved in STAR.

"It's a remarkable achievement," said Norman Wolmark, M.D., chairman of the NSABP and of the Department of Human Oncology at Allegheny General Hospital in Pittsburgh, Pa. "Women at increased risk for developing breast cancer chose to be proactive about finding options to prevent the disease. We owe a debt of gratitude to these women who are leading the charge in preventing breast cancer."

Those participating in STAR are randomly assigned to take either tamoxifen or raloxifene for five years. Women enrolled in STAR will continue to receive close follow-up care until study results are known. STAR began in 1999 and some women have already completed their five years of study treatment.

"I've taken my last pill, but the research team is still following my situation very closely," said Judy Hupfeld, a STAR participant from Coralville. "It gives me a real sense of security to know that they are still monitoring my health so carefully."

Tamoxifen, a mainstay in breast cancer treatment, is also approved for breast cancer risk prevention in women with an increased risk of getting the disease. Raloxifene is approved to prevent and treat osteoporosis in postmenopausal women. The initial results of the STAR trial should be available by early 2006.

"Data from these large-scale clinical trials in breast cancer prevention is critically important and will help women at increased risk for breast cancer make choices about their health," stated Leslie Ford, M.D., associate director for clinical research in the National Cancer Institute's (NCI) Division of Cancer Prevention. "The women who have chosen to join this trial are advancing the medical frontier and should be congratulated."

STAR is conducted by the National Surgical Adjuvant Breast and bowel Project (NSABP), a not-for-profit cancer research group, and is funded primarily by the National Cancer Institute. Eli Lilly and Company of Indianapolis, Ind., has provided the raloxifene and AstraZeneca Pharmaceuticals of Wilmington, Del., has provided the tamoxifen for the trial at no charge.

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 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.