STAR logo Tulane Cancer Center
Tulane Cancer Center
Announces Participation
in Major Breast Cancer Prevention Trial:
The Study of Tamoxifen and Raloxifene (STAR)

Related pages:
TCC fact sheet on STAR
 Other clinical trials at Tulane
STAR information page at the website of the NSABP
Closed to accrual, effective September 2004.
The Study of Tamoxifen and Raloxifene (STAR) (NSABP P-2), one of the largest breast cancer prevention studies ever, is now recruiting volunteers at more than 400 centers across the United States, Canada, and Puerto Rico. The Tulane Cancer Center is one of these sites in the New Orleans area that will be participating in the trial.

"We are excited about bringing this important study to the New Orleans area," said Roy S. Weiner, M.D., Director of the Tulane Cancer Center. "Women everywhere are at risk for breast cancer, and we are pleased that New Orleans women will have the chance to participate in this important study."

The trial will involve 22,000 postmenopausal women (nationwide) at increased risk of breast cancer. The purpose is to determine whether the osteoporosis prevention drug raloxifene (Evista) is as effective in reducing the chance of developing breast cancer as tamoxifen (Nolvadex) has proven to be.

Tulane Cancer Center is part of the National Surgical Adjuvant Breast and Bowel Project (NSABP), the network of research professionals that will conduct STAR, which is supported by the National Cancer Institute (NCI).

NSABP chairman Norman Wolmark, M.D. notes that "studies of raloxifene suggest it has the potential to prevent breast cancer. The only way to prove that potential is to do a clinical trial in which the risks and benefits of raloxifene are directly compared to the risks and benefits of tamoxifen."

Tamoxifen was shown to reduce the chance of developing breast cancer by about 50% in the Breast Cancer Prevention Trial (BCPT), a study of over 13,000 premenopausal and postmenopausal women at high risk of breast cancer. Results of this trial were announced a year ago. In the BCPT, half the women took tamoxifen and half took a placebo (an inactive pill that looked like tamoxifen). Participants taking tamoxifen also had fewer fractures of the hip, wrist, and spine than women taking the placebo.

However, the drug increased the women's chances of developing four potentially life-threatening health problems: endometrial cancer (cancer of the lining of the uterus), deep vein thrombosis (blood clots in large veins), pulmonary embolism (blood clot in the lung), and possibly stroke. The U.S. Food and Drug Administration (FDA) approved the use of tamoxifine to reduce the incidence of breast cancer in women at increase risk of the disease in October, 1998.

The NCI notes that while tamoxifen is a medically proven intervention, it is not perfect. Women at an increased risk of breast cancer need options with minimal side effects, and STAR is a concerted effort to find one.

Raloxifene was approved in December 1997 by the FDA to prevent osteoporosis and has been in clinical trials for about five years. Women taking raloxifene in studies of osteoporosis have had an increased chance of developing deep vein thrombosis or pulmonary embolism similar to tamoxifen, but not an increased risk of endometrial cancer. STAR will compare the long-term safety of raloxifene and tamoxifen.

Women who participate in STAR must be postmenopausal, at least age 35, and have an increased risk of breast cancer as determined by their age, family history of breast cancer, personal medical history, age at first menstrual period, and age at first live birth. They will also go through a process known as informed consent, during which they will learn about the potential benefits and risks before deciding whether to participate in STAR.

Once a woman chooses to participate, she will be randomly assigned to receive either tamoxifen (20 mg) or raloxifene (60 mg) daily for five years and will have regular follow-up examinations, including mammograms and gynecological exams. The trial is double-blinded which means participants will not know which drug they are taking. The maker of tamoxifen, Zeneca Pharmaceuticals and the maker of raloxifene, Eli Lilly, are providing their drugs for the trial without charge.

The Tulane Cancer Center is a STAR satellite subcenter partnering with the University of Michigan. Tulane has subsatellite centers located in New Orleans, Baton Rouge, Slidell, Alexandria, Thibodeaux, North Monroe, Pascagoula, Mississippi, and Montgomery and Mobile, Alabama, and Pensacola, Florida. For more information about STAR, please contact the Tulane Cancer Center at 1-800-588-5800 (press *). In addition to Tulane, the Ochsner Cancer Institute (842-3708) and LSU Medical Center's Stanley S. Scott Cancer Center (568-5225) will be participating in the STAR trial. Information is also provided on NSABP's web site at http://www.nsabp.pitt.edu or NCI's clinical trials web site at http://cancertrials.nci.nih.gov.
The full index of all active clinical trials at the Tulane Cancer Center is at http://www.som.tulane.edu/cancer/protocols/default.html.

The on-line database of clinical trials nationwide of the U.S. National Institutes of Health is available on the Web at http://clinicaltrials.gov.
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