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M. D. Anderson Supports Gold-Standard Federal Findings Recommending Tamoxifen to Prevent Breast Cancer in High-Risk Women

M. D. Anderson Supports Gold-Standard Federal Findings Recommending Tamoxifen to Prevent Breast Cancer in High-Risk Women
M. D. Anderson News Release 7/01/02
Two new findings, which underscore the power of tamoxifen to help prevent breast cancer as well as the risk the drug may pose, are prompting physicians at The University of Texas M. D. Anderson Cancer Center to recommend that women talk to their doctors about the drug before taking it to reduce risk of the disease.

M. D. Anderson is endorsing the findings of the U.S. Preventive Services Task Force urging health professionals to counsel women at high risk for breast cancer about the chemopreventive agent tamoxifen to prevent the disease. The agency also advised that women at low or average breast cancer risk not take tamoxifen. 

The U.S. Preventive Services Task Force report will be published in the July 2 issue of Annals of Internal Medicine.

A panel of experts comprise the Task Force, regarded by clinicians nationally as the gold standard in preventive health care recommendations. The Agency for Healthcare Research and Quality, a program of the U.S. Department of Health and Human Services, sponsors the independent panel of experts comprising the Task Force.

"This reconfirms, at the highest level, the good news that healthy women at high risk for breast cancer can take action to reduce their risk," says Dr. Therese Bevers, medical director of the institution's Cancer Prevention Center.  "We can say with confidence to high-risk women, 'Chemoprevention works. Take tamoxifen, and reduce your risk by half.'"

The second federal finding was a warning issued June 28 by the Food and Drug Administration (FDA) that identified a new complication in women taking tamoxifen for breast cancer prevention.  The agency found tamoxifen may increase risk of uterine sarcoma, an extremely rare form of cancer of the uterus. The warning is directed only at women at high risk of developing breast cancer - those who research has shown may reduce their risk with tamoxifen.

Experts all agree that tamoxifen, used to treat breast cancer for two decades, should continue as a front-line drug to treat the disease.

In 1998, the FDA recommended that high-risk women take tamoxifen to reduce their risk.  Results of the landmark Breast Cancer Prevention Trial (BCPT) provided the impetus for these first-ever federal agency recommendations for chemoprevention - taking a pill to prevent cancer. BCPT yielded the finding that tamoxifen reduced breast cancer risk by 49 percent.

"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 is participating in the large-scale, national Study of Tamoxifen and Raloxifene (STAR), a clinical trial measuring 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. In its third year of subject recruitment, M. D. Anderson remains the single largest recruitment site of 400 participating sites throughout the U.S., Canada and Puerto Rico. 

High-risk women are identified as over age 40 with a mother, sister or daughter diagnosed with breast cancer, or with a personal history of atypical cells found during breast biopsy. For these women, tamoxifen's risk-reduction benefit outweighs the drug's potential side effects, including blood clots in the legs or lungs and increased endometrial cancer risk, according to the Task Force report.

Women interested in enrolling in STAR may call the "STAR line" at (713) 792-8064 or visit the STAR website. For more information about breast cancer, call the National Cancer Institute's Cancer Information Service at 1-800-4-CANCER.


© 2015 The University of Texas MD Anderson Cancer Center