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Release: May 25, 1999

UI is main center for national breast cancer prevention study

IOWA CITY, Iowa -- Women in Iowa and Illinois who have a high risk for developing breast cancer will have the opportunity to enroll in a nationwide study to test a medication that researchers hope will prevent the disease.

Currently, a medication called tamoxifen is the only proven method of preventing breast cancer. A study of 13,000 women showed tamoxifen reduced by 50 percent the development of a first breast tumor in women considered to be at high risk for the disease. That made tamoxifen the first drug found to prevent cancer, although it is not yet clear if the protection is permanent.

Researchers believe that the medication they are about to study, called raloxifene, may also decrease a woman's risk for developing breast cancer.

Peter Jochimsen, M.D., UI professor of surgery and a surgical oncologist with University of Iowa Health Care, and Keith Wright, M.D., of Oncology Associates in Cedar Rapids, will serve as the study's principal investigators in eastern Iowa. The research project is dubbed, "Study of Tamoxifen and Raloxifene," or STAR.

"We don't know for sure if raloxifene will be as effective as tamoxifen in preventing breast cancer," said Jochimsen. "We need to test it scientifically. We hope raloxifene will eventually prove to be as effective as tamoxifen in preventing breast cancer, while also perhaps having the added advantage that it will not increase the risk for cancer of the endometrium."

Tamoxifen has an effect upon the lining of the uterus, called the endometrium. That effect can result in endometrial cancer, but when it is diagnosed in the early stages, the cure rate is high. Preliminary studies indicate that raloxifene doesn't appear to increase the risk of endometrial cancer.

Raloxifene has already been approved by the Food and Drug Administration for the prevention of bone loss, a process called osteoporosis, leading to reduction in fractures of the hip, wrist and spine. It also appears to protect women from heart disease. "We just don't yet know the long-term benefits or risks of raloxifene," said Jochimsen. "STAR should give us those answers that are so important for protecting the health of women."

STAR begins today. The study is sponsored by the National Cancer Institute and will be conducted by research professionals who are members of the National Surgical Adjuvant Breast and Bowel Project. Researchers plan to enroll 22,000 postmenopausal women in the trial, which is expected to last five to 10 years. All women participating in STAR will take either raloxifene or tamoxifen.

Researchers will evaluate women to determine if they are eligible to enroll in STAR. Women generally have a higher risk for developing breast cancer if they are over 60, have a family history of breast cancer, have had noninvasive breast cancer or pre-cancerous breast abnormalities, began to menstruate before age 12, and have not had any children or had their first child after age 30.

There are more than 400 STAR research centers, including Des Moines, Cedar Rapids and Iowa City. In addition to the main centers, there are satellite sub-centers that will enable women to enroll in STAR closer to home. Those sites include the Bliss Cancer Center - McFarland Clinic in Ames; Cedar Valley Medical Specialists in Waterloo; Genesis Medical Center in Davenport; Hinsdale Hematology Oncology Associates in Hinsdale, Ill.; Medical Associates in Clinton; Trinity Medical Center Cancer Research in Rock Island, Ill.

For more information about the study, contact the UI Cancer Information Service at (319) 356-4262 or 800-237-1225.