Subjects sought for cancer study

Women at high risk for breast cancer who qualify may enroll at UT Southwestern in the largest North American breast cancer prevention trial ever undertaken.

The nationwide Study of Tamoxifen and Raloxifene (STAR) will determine if the drug raloxifene can prevent breast cancer better and with fewer side effects than tamoxifen.

The National Surgical Adjuvant Breast and Bowel Project began recruiting post-menopausal women for STAR in July 1999 and plans to complete enrollment this summer with 19,000 participants. Results of the study funded by the National Cancer Institute are expected by 2006.

Dr. Marilyn Leitch, medical director of the Southwestern Center for Breast Care, professor of surgical oncology and holder of the S.T. Harris Family Distinguished Chair in Breast Surgery, is overseeing the study at UT Southwestern.

STAR is designed to determine whether the osteoporosis prevention and treatment drug raloxifene is as effective as tamoxifen in reducing breast cancer risk. It is the follow-up study to the landmark Breast Cancer Prevention Trial, published in 1998, which led to tamoxifen being approved by the Food and Drug Administration for risk reduction in women at increased risk for developing breast cancer.

STAR includes post-menopausal women at high risk for breast cancer due to a family history of breast cancer and a combination of personal medical factors. These factors are used to estimate a woman's individual risk for developing the disease in the next five years and in her lifetime.

In the study, participants are being randomly assigned to receive either 20 milligrams of tamoxifen or 60 mg of raloxifene daily with regular follow-up examinations until the results of the trial are known. The drugs will be provided free during the five-year trial.

For more information or to enroll, contact Karen Smith, senior research nurse at the Harold C. Simmons Comprehensive Cancer Center, at 214-648-7042.


Media contact: Scott Maier