Originally Released: June, 1999
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The University of Maryland Greenebaum Cancer Center will participate in one of the largest breast cancer prevention studies ever conducted, sponsored by the National Cancer Institute. The STAR trial, which stands for Study of Tamoxifen and Raloxifine, will be conducted at more than 400 cancer institutions and enroll more than 22,000 women.
The study will compare the drug tamoxifen, a commonly used medication in treating breast cancer, to raloxifene, a drug prescribed for postmenopausal women to reduce the risk of osteoporosis. The researchers will evaluate whether raloxifene is as effective as tamoxifen at preventing breast cancer in women who have not had the disease, and whether it offers any benefits over tamoxifen.
In an earlier prevention study, researchers found that tamoxifen was able to decrease the incidence of breast cancer by 49 percent among women at high risk for the disease, including those with close family relatives who had been diagnosed with breast cancer and older women.
"Even with the positive results of that study, tamoxifen should not be prescribed routinely for all women at high risk of breast cancer," says Katherine Tkaczuk, M.D., director of the Breast Evaluation and Treatment Program at the University of Maryland Greenebaum Cancer Center.
"Tamoxifen increases the risk of endometrial cancer, but so far, we are not aware of a similar side effect from raloxifene," says Dr. Tkaczuk, an assistant professor of medicine and oncology at the University of Maryland School of Medicine. She was also an investigator in the earlier tamoxifen prevention study at the Greenebaum Cancer Center.
The study will include postmenopausal women who are at increased risk of developing breast cancer, as determined by their age, family history of breast cancer, personal medical history, age at first menstrual period and age of first live birth. The participants will be randomly assigned to receive either tamoxifen or raloxifene for five years, and neither they, nor their doctors will know which drug they are taking until the end of the study. Participants will receive close follow-up care, including mammograms, physical exams and gynecological exams for at least seven years.
"The incidence of breast cancer has been rising in recent years," says Barry Meisenberg, M.D., director of the Division of Hematology and Oncology at the University of Maryland School of Medicine and deputy director of Clinical Affairs at the University of Maryland Greenebaum Cancer Center.
"We are making progress in treating breast cancer, but it is also essential to find ways to prevent the disease. This new study is important because it may lead to another option to help high risk women," Dr. Meisenberg says.
Women who want to find out more about the study should call the University of Maryland Greenebaum Cancer Center at 410-328-7855, or toll-free 1-800-492-5538.
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