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Important Points About STAR

The Study of Tamoxifen and Raloxifene, known as STAR, is one of the largest breast cancer prevention trials ever undertaken.

STAR is also the first trial to compare a drug proven to reduce the chance of developing breast cancer with another drug that has the potential to reduce breast cancer risk. All participants receive one or the other drug for five years.

19,000 postmenopausal women at high-risk of breast cancer will participate in STAR.

There are more than 400 STAR sites in the United States, Puerto Rico, and Canada.

Every woman considering STAR will have her risk of breast cancer assessed by a computerized program that will show how her risk compares to other women her age.

Breast cancer risk is based on age, family history of the disease, and personal medical history.

Tamoxifen (trade name Nolvadex®) was proven in the Breast Cancer Prevention Trial to reduce breast cancer incidence by 49 percent in women at increased risk of the disease. The U.S. Food and Drug Administration (FDA) approved the use of tamoxifen to reduce the incidence of breast cancer in women at increased risk of the disease in October 1998. Tamoxifen has been approved by the FDA to treat women with breast cancer for more than 20 years and has been in clinical trials for about 30 years.

Raloxifene (trade name Evista®) was shown to reduce the incidence of breast cancer in a large study of its use to prevent and treat osteoporosis. This drug was approved by the FDA to prevent osteoporosis in postmenopausal women in December 1997 and has been under study for about five years.

The trial is limited to postmenopausal women because one of the drugs, raloxifene, has not been adequately safety tested in premenopausal women. Such safety testing is under way.

Both tamoxifen and raloxifene have known side effects. Any women interested in participating in the trial will be fully informed of the benefits and potential risks of these drugs.

The most common side effects of either drug are hot flashes and vaginal discharge. Treatments to eliminate or minimize side effects are available.

Serious side effects are known to occur in women taking tamoxifen, namely endometrial cancer, blood clots in the leg or lung, and possibly stroke. Women who have had a hysterectomy are not at risk for endometrial cancer.

Serious side effects are known to occur in women taking raloxifene, namely blood clots. Since this drug has not been under study as long as tamoxifen, not as much is known about any side effects from long-term use.

Women with certain medical conditions will not be eligible to participate in STAR: Women with a history of cancer, blood clots, stroke, or certain types of heartbeat irregularities cannot participate. Women whose high blood pressure or diabetes is uncontrolled cannot participate.

Postmenopausal women in the United States and Puerto Rico who are interested in participating in STAR can call the National Cancer Institute’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for information in English or Spanish. The number for callers with TTY equipment is 1-800-332-8615.

Postmenopausal women in Canada who are interested in participating in STAR can call the Canadian Cancer Society’s Cancer Information Service at 1-888-939-3333 for information in English or French.

For more information via the Internet, visit NSABP’s Web site at http://www.nsabp.pitt.edu or NCI’s clinical trials Web site at http://www.cancer.gov/clinical_trials/