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Last Call to Enroll in M. D. Anderson Breast Cancer Prevention Study

Last Call to Enroll in M. D. Anderson Breast Cancer Prevention Study
May 28 Last Day to Enroll in Continent-Wide Study
M. D. Anderson News Release 05/25/04

If you’re interested in helping researchers learn how to prevent breast cancer for future generations of women, there is one more chance to enroll in the Study of Tamoxifen and Raloxifene (STAR).

Friday, May 28, 2004, is the last day for potential participants to call The University of Texas
M. D. Anderson Cancer Center to enroll in STAR. With more than 18,700 women enrolled, the study is not accepting new participants after five years of recruitment.

M. D. Anderson has been one of more than 500 participating sites in North America recruiting women to the largest cancer prevention study ever conducted, says Therese Bevers, M.D., medical director of M. D. Anderson’s Cancer Prevention Center and STAR principal investigator at M. D. Anderson.

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.

“We’re hoping to enroll a total of 19,000 women throughout the United States, Canada and Puerto Rico to reach our study goal,”Bevers says. “The number of women enrolled to date is remarkable, considering the eligibility criteria of being postmenopausal and at increased risk for breast cancer.”

Since the study began in July 1999, M. D. Anderson has enrolled more than 369 women, including nearly 8 percent minority participation.

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.

"Tamoxifen is a medically proven intervention, but it does have drawbacks," 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."

“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,” Bevers says. “It was a matter of waiting until the disease developed, then treating the cancer.”

Nationally, the African-American recruitment goal has been 500 women.  Previous large-scale studies have averaged about 3 percent total minority participation, including all minority groups.
STAR targeted enrollment of African-American women because, although breast cancer incidence is lower in African-American women, when diagnosed, they are 21 percent more likely to die of the disease than women of any other racial or ethnic background, Bevers says.

Analyses of tamoxifen use in women with breast cancer has shown the drug works equally well in white and African-American women. Worta McCaskill-Stevens, M.D., of the NCI’s Division of Cancer Prevention, presented these findings at the American Society of Clinical Oncology’s annual meeting in 2000.

“The benefits and risks of tamoxifen are the same in African-American and white women.  Women of all races can feel comfortable about considering STAR if they are at increased risk of breast cancer,” McCaskill-Stevens says.

Despite progress in the early detection and treatment of the disease, about 215,990 women will be diagnosed with breast cancer during 2004, according to the American Cancer Society. About 40,110 women are expected to die from the disease this year. 

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.

All participants take either tamoxifen or raloxifene daily for five years, returning to
M. D. Anderson for regular follow-up examinations, including mammograms and gynecologic exams.

For more information, or to join STAR before enrollment closes, visit the Web site at mdanderson.org/star or call the "STAR line" at M. D. Anderson at (713) 792-8064. Additional information is available from the National Cancer Institute's Cancer Information Service at
1-800-4-CANCER. Both numbers offer information in English and Spanish.


© 2014 The University of Texas MD Anderson Cancer Center