Update

22,000 women are sought for the landmark breast cancer prevention Study of Tamoxifen and Raloxifene (STAR). In its first year, STAR enrolled 6,139 post-menopausal women who were at increased risk for breast cancer.

Purpose

STAR seeks to determine if the osteoporosis prevention and treatment drug, Raloxifene (Evista^®) is as effective as Tamoxifen (Novaldex^®) in reducing breast cancer risk. In October 1998, the U.S. Food and Drug Administration approved the use of Tamoxifen to reduce the incidence of breast cancer in high risk women. It had been shown to reduce the chances of developing breast cancer by about half in a study of 13,000 pre- and post-menopausal women. aloxifene was also shown to reduce the incidence of breast cancer in women in a large osteoporosis trial study.

Participation Guidelines

To be eligible for the STAR trial a woman must be 35 years of age or older, postmenopausal, and have an increased risk for breast cancer based on risk factors such as age, family history of breast cancer, and personal medical history. The STAR trial is limited to postmenopausal women because Raloxifene has not been well tested in premenopausal women. Women are ineligible if they have a history of blood clots, uncontrolled hypertension, uncontrolled diabetes, acute or chronic atrial fibrillation, or currently use blood thinners or hormone replacement therapy (HRT). Women need to be off of HRT for three months before starting Tamoxifen or Raloxifene.

Women of all ethnicities and races are encouraged to participate in STAR. About five percent of the first 6,000 women enrolled in STAR during its first year were minority women. Studies have shown that Tamoxifen works equally well in white and African American women with breast cancer.

Benefits

Any woman contacting a STAR trial site will receive a free assessment of her breast cancer risk and a written risk profile showing the potential benefits and risks of the drugs given. Women considering participation in STAR will go through a process known as informed consent, during which they will learn specific details about the potential

benefits and risks of Tamoxifen and Raloxifene. During the trial, participants will receive the study drug free for five years, the time period for taking the drug. Entry and follow-up exams include a yearly mammogram, twice a year clinical breast exam, routine yearly blood tests, and a yearly pelvic exam. These exams can be done at a STAR center or through a regular healthcare provider, but are not subsidized by STAR.

To Join

At over 500 health care centers across the United States, Puerto Rico, and Canada, STAR is available by contacting the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). Information on STAR can also be obtained via the Internet at http://cancertrials.nci.nih.gov or http://www.nsabp.pitt.edu. STAR is being conducted by the National Surgical Adjuvant Breast and Bowel Project and is supported by the National Cancer Institute. Additional information can be obtained from Jennifer Bucholtz, Nurse Practitioner, the Johns Hopkins Breast Center at 410-614-STAR (410-614-7827).