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Release: Aug. 7, 2000

Enrollment continues in landmark breast cancer study at UI, other sites

IOWA CITY, Iowa -- The first year of the multi-center Study of Tamoxifen and Raloxifene (STAR) saw 6,139 postmenopausal women at increased risk of breast cancer enroll in this landmark prevention study. More than 47,000 women went through an individualized, no-obligation risk assessment to determine their risk of breast cancer and weigh the pros and cons of joining the trial. Enrollment began July 1, 1999. Researchers plan to eventually enroll 22,000 women in STAR.

Many of these 47,114 women did not have an increased risk of breast cancer that would make them eligible for the trial. More than 29,300 women were eligible for the trial based on breast cancer risk alone, but had to make the choice to participate based upon their overall health and personal reasons.

"As of June 30, 2000, more than 136 women from Iowa are already participating in STAR, including 82 women at University of Iowa Hospitals and Clinics," said Peter Jochimsen, M.D., a UI professor of surgery, surgical oncologist and principal investigator on STAR. "This trial has a five-year recruitment plan, but we hope to reach our goal within the next two or three years. We are encouraging all eligible women who live in Iowa to participate."

STAR is designed to determine whether the osteoporosis prevention and treatment medication raloxifene is as effective as tamoxifen in reducing breast cancer risk. In 1998, tamoxifen was shown to reduce the chance of developing breast cancer by about half in the Breast Cancer Prevention Trial (BCPT), a study of more than 13,000 premenopausal and postmenopausal women at increased risk of breast cancer. The U.S. Food and Drug Administration (FDA) approved tamoxifen to reduce the incidence of breast cancer in October of 1998. Raloxifene was shown to reduce the incidence of breast cancer in a large osteoporosis trial, the MORE study.

More than 500 centers across the United States, Puerto Rico and Canada are enrolling participants in STAR. STAR is a study of the National Surgical Adjuvant Breast and Bowel Project (NSABP) and is supported by the U.S. National Cancer Institute (NCI).

NSABP Chairman Norman Wolmark, M.D., said, "We are pleased that so many women have joined this trial to help us answer this important medical question. We encourage women to go through the risk assessment process to learn more about their breast cancer risk and about STAR.
In the end, each woman who joins does so for her own reasons, but every single woman plays a vital role."

Women who participate 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, age at first menstrual period and age of first live birth. They also will go though a process known as informed consent, during which they will learn about the potential benefits and risks of tamoxifen and raloxifene before deciding whether to participate in STAR.

Postmenopausal women in Iowa who are interested in participating in STAR can contact UI Health Care at (319) 356-2778 or toll free at (800) 237-1225.


University of Iowa Health Care describes the partnership between the UI College of Medicine and the UI Hospitals and Clinics and the patient care, medical education and research programs and services they provide.