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Breast Cancer prevention study

July 30, 1999

FREDERICK, Md. -Frederick Memorial Hospital Regional Cancer Therapy Center is recruiting postmenopausal women who face an increased risk of breast cancer and are interested in participating in one of the largest breast cancer prevention studies ever undertaken.

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The Study of Tamoxifen and Raloxifene will include 22,000 women in the United States, Puerto Rico and Canada.

Tamoxifen was hailed for its effectiveness in reducing the chance of developing breast cancer by about 50 percent in the Breast Cancer Prevention Trial, a study of more than 13,000 women at high risk for developing the disease.

Those taking the drug also had fewer fractures of the hip, wrist and spine than women taking a placebo during the study.

However, Tamoxifen increased participants' chances of developing serious health problems, notably endometrial cancer, deep vein thrombosis, pulmonary embolism and possibly stroke. Short-term trials of Raloxifene have not shown these side effects. Both drugs are proven to help prevent osteoporosis.

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The doctors will do an initial screening by mail to see if people qualify for the study. To be accepted in the study, women must be at least 35 years old, postmenopausal and have a risk such as family history of breast cancer, a medical history of breast biopsies, but not a previous history of breast cancer.

Women with complicating medical conditions are not eligible to participate.

Some patients will receive Tamoxifen and others will receive Raloxifene taken by mouth once daily for five years.

Neither the participant nor her physician will know which drug she is receiving, but all patients will receive one of the two active medications. Regular follow-up examinations, including mammograms and gynecological exams, will continue throughout the study.

The FMH Regional Cancer Therapy Center is part of National Surgical Adjuvant Breast and Bowel Project, the network of research professionals that will conduct the study, which is supported by National Cancer Institute.

For information or to inquire about participating in the study, call FMH Regional Cancer Therapy Center at 1-301-662-8477 or National Cancer Institute at 1-800-4-CANCER (1-800-422-6237). Access NCI's clinical trial Web site at cancertrials.nci.nih.gov or www.nsabp.pitt.edu.

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