TMC Institutions to Collaborate on Recruitment Efforts for STAR Trial

Three Texas Medical Center institutions are joining efforts to recruit participants for the Study of Tamoxifen and Raloxifene (STAR), the nationwide clinical trial comparing the drugs' effectiveness for breast cancer prevention.

To be eligible for the STAR trial, participants must be postmenopausal and at increased risk for developing breast cancer.

Women can be enrolled at St. Luke's Episcopal Hospital, The University of Texas M. D. Anderson Cancer Center and by Baylor College of Medicine physicians at the Breast Care Center at Baylor and The Methodist Hospital and at Ben Taub General Hospital. The institutions plan to team up at citywide health-related events and locations, including the Susan G. Komen Breast Cancer Foundation Race for the Cure®, The Rose community breast center, and others over the course of the five-year recruitment period.

Breast cancer has, unfortunately, touched the life of Beverly Bradford more than once. Both her mother and sister lost their battles with the disease. Bradford saw the STAR trial as a way to educate others about breast cancer and participate in an effort to possibly prevent it in the future. As a participant in the STAR trial, Bradford will join women at more than 400 centers in the United States, Puerto Rico and Canada in one of the largest breast cancer prevention studies to date. Study coordinators hope to enroll a total of 22,000 women in the study; local organizers plan to recruit between 500-600 participants.

"We want to increase the diversity in STAR to more accurately reflect the population of women," says Dr. Therese Bevers, STAR principal investigator at M. D. Anderson.

African-American women are at particularly high risk of breast cancer.

"Although breast cancer is diagnosed more often in Caucasian women, the mortality rate for African-American women is 21 percent higher," says Dr. Powel Brown, STAR principal investigator at Baylor College of Medicine. Past research has shown that this is because many African-American women are not diagnosed until the disease has reached more advanced stages.

The double-blind study, meaning neither the patient nor her physician knows which drug is being administered, is being conducted to determine the best drug to reduce the incidence of breast cancer in women at high risk. The study will look at not only the effectiveness of each drug, but also their long-term safety.

Dr. Philip Salem, STAR principal investigator at St. Luke's, says it is a "win-win" trial because the two drugs for comparison have both shown to be effective.

Tamoxifen has been used as a treatment for breast cancer for more than 20 years. In May 1998, results of the Breast Cancer Prevention Trial (BCPT) revealed that tamoxifen could also decrease the incidence of breast cancer in high risk groups. The STAR trial, which opened enrollment last May, is a follow-up to the BCPT.

Tamoxifen will be compared to raloxifene, a drug approved by the U.S. Food and Drug Administration in 1997 to prevent osteoporosis in postmenopausal women. Studies have shown that women taking raloxifene for osteoporosis also developed fewer breast cancers than women taking a placebo.

Judith Jordan, who was taking the placebo in the BCPT, says she believes in what the researchers are doing. Jordan's risk factors, including a family history (both her mother and grandmother had breast cancer), made her eligible to participate in the STAR trial. She says she would like women who may be thinking about participating to "give us a chance to see if it is for you."

Individuals interested in enrolling in STAR may call the National Cancer Institute at 1-800-4-CANCER. STAR is funded by the National Surgical Adjuvant Breast and Bowel Project and supported by the National Cancer Institute.

- From St. Luke's Episcopal Hospital, The University of Texas M. D. Anderson Cancer Center and Baylor College of Medicine with additional reporting by Kristina Van Arsdel

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©2006 Texas Medical Center

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