From OncoLog, July/August 2003, Vol. 48, No. 7/8
UPDATE
Study of Tamoxifen and Raloxifene (STAR) Nearing Completion: Recruitment
Efforts Focus on Women in Minority, Medically Underserved Populations
by Gayle Nesom
In October 1998, the first major Breast Cancer Prevention Trial (BCPT) ended dramatically and prematurely when tamoxifen was found to decrease by 49% the incidence of invasive breast cancer in women at increased risk. One year later, the National Surgical Adjuvant Breast and Bowel Project opened a second trial, this one to compare the effects and long-term safety of tamoxifen with those of raloxifene, an osteoporosis prevention drug that may also reduce the risk of breast cancer.
Nationwide, more than 16,000 women have enrolled in the Study of Tamoxifen and Raloxifene (STAR), according to Therese Bevers, M.D., an assistant professor in the Department of Clinical Cancer Prevention and medical director of the Cancer Prevention Center at The University of Texas M. D. Anderson Cancer Center. The total enrollment goal of STAR is 19,000 participants, down from an initial 22,000.
“Fewer women are needed than originally planned because the women who have volunteered have been at higher risk than anticipated,” Dr. Bevers said. As a result, the study will be able to accrue the defined number of events (breast cancer diagnoses) required for a valid analysis more quickly. Data from the study should be available by early 2007.
The trial is open to postmenopausal women older than 35 years who meet either of the study’s two criteria: they must be at increased risk of breast cancer, as defined by the Gail risk-assessment model, which was used in the first BCPT, or they must have been diagnosed with lobular carcinoma in situ (LCIS), a condition that is sometimes a precursor of invasive breast cancer. The trial is limited to postmenopausal women because raloxifene’s long-term safety has not been adequately tested in premenopausal women.
Recruitment at M. D. Anderson and its satellite trial sites has been successful, according to Dr. Bevers, and several recruitment initiatives are in place. “We recognize that potential participants may not be able to travel to Houston,” said Dr. Bevers, “so getting the trial out to other communities, particularly those with large minority populations, is a big focus. We are just about to open our seventh and eighth satellite sites, which will make participating through M. D. Anderson possible in Houston, El Paso, Laredo, Beaumont, Lufkin, and Tyler, Texas, as well as Shreveport, Louisiana, and Orlando, Florida.”
In Houston, M. D. Anderson has established a collaborative relationship, called Houston STAR, with the Texas Cancer Institute/St. Luke’s Episcopal Hospital and the Baylor College of Medicine and Methodist Hospital Breast Care Center.
As part of this collaboration, a community outreach coordinator was hired to recruit minority and medically underserved women. “African-American women are at higher risk of dying of breast cancer than women in other racial groups, and we would like to reach as many women in this population as possible,” Dr. Bevers said.
M. D. Anderson has a professional outreach coordinator who talks with health-care professionals about the trial and about their patients’ opportunities for participating. The coordinator also gives physicians feedback about their patients’ participation in the study.
Dr. Bevers and her colleagues also are exploring an opportunity that would enable them to distribute breast cancer risk assessment and prevention information to a large group of women in Texas. “Besides recruitment, a major goal is to make requesting a cancer risk assessment as common as requesting a mammogram. Women who learn that they are at increased risk need to know their options for decreasing the risk,” she said.
Recruitment for STAR will continue through 2004. Physicians who want more information are encouraged to call Diane Birkner, professional outreach coordinator, at (713) 745-8361. Women who would like information about participating in the trial should call M. D. Anderson’s STAR line at (713) 792-8064 or toll free at (866) 699-4400. Additional information is available at M. D. Anderson, the National Surgical Adjuvant Breast and Bowel Project, on the National Cancer Institute’s clinical trials Web site, or from the Cancer Information Service at (800) 4-CANCER (422-6237).
For more information on this topic or for questions about M. D. Anderson’s treatments, programs, or services, call askMDAnderson at (877) MDA-6789.
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