National Cancer Institute Launches Capital Area SERM Study

National Cancer Institute
Thursday, 20 May 1999

The National Cancer Institute (NCI) has launched the first long-term clinical research study to evaluate the safety of the drug raloxifene (Evista®) in premenopausal women at high risk of breast cancer. Early studies of raloxifene, an osteoporosis prevention drug, suggest it may also help reduce the risk of breast cancer. The Capital Area SERM Study will evaluate the effects of raloxifene on premenopausal women between the ages of 23 and 47 who are at an increased risk for breast cancer. Researchers will monitor the drug's effects on bone density, hormone levels, the uterus, and ovaries.

"Early research shows that raloxifene may reduce the incidence of breast cancer," said NCI principal investigator JoAnne Zujewski, M.D. "Through this study we hope to learn what potential long-term side effects may result from its use in premenopausal women."

The study is seeking 62 premenopausal women who have an increased risk of breast cancer as determined by their age, previous breast biopsies, family history of breast cancer, age at first menstrual period, and age at first live birth. Participants must also be women who:

- Are willing to use nonhormonal methods of contraception and have regular menstrual cycles;
- Are not pregnant or lactating;
- Have not had a hysterectomy;
- Are not allergic to raloxifene; and
- Do not have a history of infertility, cirrhosis of the liver, bleeding disorders, or blood clots.

Study volunteers will take raloxifene orally every day for two years. Participants will visit the NCI on a regular basis over three years for checkups and tests. Patients will also be carefully monitored for the development of breast cancer.

"Once adequate information about raloxifene's safety in premenopausal women has been obtained through smaller studies such as this one, large randomized studies can be conducted to determine whether raloxifene will reduce the risk of developing breast cancer," said Zujewski.

The study takes place in Bethesda, Md., at the NCI on the campus of the National Institutes of Health and the Breast Care Center at the National Naval Medical Center. Women who are interested in participating in the study or who would like additional information should call the Clinical Studies Support Center at 1-888-624-1937, Monday through Friday, 9 a.m. to 5 p.m., Eastern time.

For more information, or to contact National Cancer Institute, see their website at: www.cancer.gov