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| STAR Clinical Trials |
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 The Study of Tamoxifen and Raloxifene, or STAR, one of the largest breast cancer prevention studies ever, is now recruiting volunteers at more than 400 centers across the United States, Canada, and Puerto Rico. Thompson Cancer Survival Center (TCSC) is one of the sites chosen by the study sponsor to begin immediate accrual to the trial. The trial will include 22,000 postmenopausal women at increased risk of developing breast cancer to determine whether the osteoporosis-prevention drug raloxifene (Evista) is as effective in reducing the chance of developing breast cancer as tamoxifen has been proven.Tamoxifen has been shown to reduce the chance of developing breast cancer by about half in the Breast Cancer Prevention Trial (BCPT), a study of more than 13,000 pre- and postmenopausal women at high risk of developing the disease who took either tamoxifen or a placebo for five years. TCSC was the premier site in the state of Tennessee for the BCPT and accrued over 80 women in the Knoxville area to the study. Participants taking tamoxifen also had fewer hip, wrist, and spine fractures than the women in the placebo group. However, the drug was shown to increase the women's chances of developing endometrial cancer, deep vein thrombosis (blood clot in the leg or arm), pulmonary embolism (blood clot in the lung), and possibly stroke. For this reason, women who have a history of any of these conditions should not take tamoxifen therapy. Based on the results of the study, the FDA approved the use of tamoxifen to reduce the incidence of breast cancer in high risk women in October 1998. Raloxifene was approved in December 1997 by the FDA for the prevention of osteoporosis. During the clinical trials for the drug, raloxifene was shown to reduce the risk of breast cancer in women, but it also carried an increased chance of developing blood clots--similar to the risk seen with tamoxifen. In these studies, raloxifene did not increase the risk of endometrial cancer. 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 first live birth. Once a woman chooses to participate, she will be randomly assigned to receive either tamoxifen or raloxifene daily for five years and will have regular follow-up evaluations at the Cancer Center. These include free RN-performed breast exams every six months and free lab work annually. There are also programs for economically disadvantaged women to have their annual mammogram covered, if needed. For the convenience of women in the region, STAR participants may be seen at clinics at either TCSC-downtown, the Oak Ridge Breast Center, or the Mammography Department at Fort Sanders Sevier Medical Center
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