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Texas Medical Center Leads North America in STAR Subject Enrollment During Initial Year of Five-year Recruitment

Texas Medical Center Leads North America in STAR Subject Enrollment During Initial Year of Five-year Recruitment
M. D. Anderson News Release 07/28/00

The Texas Medical Center recruited more participants than any of the over 500 participating sites in the U.S., Canada and Puerto Rico during the first year of the Study of Tamoxifen and Raloxifene (STAR), the largest breast cancer prevention study ever conducted.

Participating Texas Medical Center institutions include Baylor College of Medicine/The Methodist Hospital, St. Luke's Episcopal Hospital and The University of Texas M. D. Anderson Cancer Center.

In January, the three institutions took the unprecedented step of agreeing to collaborate collaborating on subject recruitment at citywide health-related events and locations over the five-year recruitment period. These recruitment efforts will be conducted at sites around Houston, including the Susan G. Komen Breast Cancer Foundation Race for the Cure, The Rose community breast center and more. "

As of June 30, 2000, more than 520 women from Texas are already participating in STAR, including 131 women from Houston," says Dr. Therese Bevers, STAR principal investigator at M. D. Anderson and medical director of the Cancer Prevention Center. Other states with the most women enrolled are Pennsylvania, with 415 participants enrolled, California with 359 and Illinois with 333.

Throughout all participating sites, 6,139 postmenopausal women at increased risk of breast cancer enrolled in this landmark prevention study during the last year. More than 47,000 women underwent individualized, no-obligation risk assessment to determine their risk of breast cancer and weigh the pros and cons of joining the trial.

"This trial has a national goal of recruiting 22,000 women in five years," says Dr. Powel Brown, a physician at the Breast Care Center at Baylor and Methodist and principal investigator at the STAR site at Baylor. "We hope to reach our goal earlier, within the next few years. We encourage all eligible women in the Houston area to participate.

STAR researchers are measuring the efficacy of two drugs, tamoxifen and raloxifene, to determine which is better for preventing breast cancer with fewer side effects. Eligible women must be postmenopausal and at increased risk for developing breast cancer.

The ages of women joining STAR in the first year were age 35-49, 9.4 percent; age 50-59, 50.2 percent; age 60 and older, 40.4 percent.

Many of the 47,114 women seeking to enroll weren't at increased risk of breast cancer and therefore weren't eligible to participate; 29,303 women were eligible based on breast cancer risk alone, but had to make the choice to participate based on their overall health and personal reasons.

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. Raloxifene was shown to reduce the incidence of breast cancer in a large osteoporosis trial.

Tamoxifen and raloxifene may increase a woman's chances of developing several rare, but potentially life-threatening health problems: deep vein thrombosis (blood clot in a large vein) and pulmonary embolism (blood clot in the lung). Tamoxifen use may also increase a woman's risk of stroke and endometrial cancer (cancer of the lining of the uterus) at a rate similar to estrogen replacement therapy. In ongoing studies, raloxifene has not been associated with increased endometrial cancer risk. STAR will help further define the risks and benefits of tamoxifen and raloxifene therapy.

"We are making every effort to remove barriers to participation to make the STAR trial easily accessible to all women," says Dr. Susan Escudier, STAR collaborator at St. Luke's and vice-chair of St. Luke's Cancer Committee.

"For this reason, all participants receive free blood tests and risk assessment for breast cancer, and these are valuable services," she says. Financial aid is available to women who qualify to fulfill study requirements.

Once a woman decides to participate, she is randomly assigned to receive either 20 mg tamoxifen or 60 mg raloxifene daily for five years. Every woman receives regular follow-up examinations.

STAR is a study of the National Surgical Adjuvant Breast and Bowel Project (NSABP) and is supported by the U.S. National Cancer Institute (NCI). The maker of tamoxifen, AstraZeneca Pharmaceuticals, Wilmington, Del., and the maker of raloxifene, Eli Lilly and Co., Indianapolis, Ind., are providing drugs for STAR for free.

Postmenopausal women interested in enrolling in STAR may call the National Cancer Institute's Cancer Information Service at 1-800-4-CANCER. For more information on the Internet, visit NSABP's Web site NCI's clinical trials website at

M. D. Anderson's Information on STAR


© 2015 The University of Texas MD Anderson Cancer Center