In 1999, Watson-Ellyson was the first woman to enroll in the Study of Tamoxifen and Raloxifene (STAR) at The University of Texas M. D. Anderson Cancer Center.
Following three years of study enrollment, breast cancer prevention researchers at M. D. Anderson continue seeking women of all races to participate in STAR, one of the largest breast cancer prevention studies ever conducted.
Because of her participation, Watson-Ellyson repeats her daily ritual, with one small addition. She takes a shower, brushes her teeth, takes her vitamins-and takes her STAR pill.
It's just that simple, as is her reason for participating.
"This research gives us hope. Sitting around worrying is worse for you," says the 60-year-old Continental Airlines ticket agent.
STAR, sponsored by the National Surgical Adjuvant Breast and Bowel Project and the National Cancer Institute, compares two drugs, tamoxifen and raloxifene, to determine which prevents breast cancer more effectively with the least side effects.
"Postmenopausal women from all racial and ethnic backgrounds are encouraged to participate in STAR, but because African-American women are more likely to die of breast cancer than any other racial or ethnic group, we particularly are encouraging them to enroll," says Dr. Therese Bevers, STAR principal investigator at M. D. Anderson.
With 266 women enrolled to date--about 66 percent of the institutional goal of 400--M. D. Anderson remains the single largest recruitment site of 400 participating sites throughout the United States, Canada and Puerto Rico. M. D. Anderson ranks third among participating sites in minority enrollment, with 48 minority women--about 18 percent of participants. During the past three years, 3,670 women have completed risk assessment forms, the initial questionnaire that determines a woman's eligibility to participate. The five-year recruitment period began July 1999.
Nationally, study organizers plan to enroll 22,000 women among participating sites. So far, 14,369 women are participating in STAR--about 65 percent of the goal. Studywide, 851 minority women have enrolled, about 6 percent of all participants. A total of 129,990 women have completed risk assessment forms.
"Tamoxifen is a medically proven intervention, but it does have drawbacks," Dr. Bevers says. "Women at an increased risk need breast cancer prevention options with a minimum of side effects, and STAR is a concerted effort to find one."
STAR is a follow-up to the landmark Breast Cancer Prevention Trial (BCPT), which yielded the finding that tamoxifen reduced breast cancer risk by 49 percent in women at high risk for developing the disease. Because of BCPT findings, the U.S. Food and Drug Administration in October 1998 approved tamoxifen to prevent breast cancer in high-risk women. Tamoxifen has been used for more than two decades to treat breast cancer.
"Until the FDA approved tamoxifen, high-risk women had no other option but to participate in vigilant screening to detect breast cancer in the earliest stages," Dr. Bevers says. "It was a matter of waiting until the disease developed, then treating the cancer."
M. D. Anderson's satellite sites include St. Luke's Episcopal Hospital in Houston, Memorial Health System of East Texas/Arthur Temple Sr. Regional Cancer Center in Lufkin, Providence Memorial Hospital in El Paso, The University of Texas Health Center in Tyler, Christus Shumpert Health System in Shreveport, La., and M. D. Anderson Cancer Center in Orlando, Fla.
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 having first child. Potential side effects of tamoxifen include blood clots in the legs or lungs and increased risk of endometrial cancer and uterine sarcoma; possible side effects of raloxifene are blood clots in the legs or lungs.
Women interested in enrolling in STAR may call the "STAR line" at 713-792-8064 or visit the Web site at www.mdanderson.org/star. For more information about breast cancer, call the National Cancer Institute's Cancer Information Service at 1-800-4-CANCER.