Protocol Number: 04-C-0044
As of December 2004, the arm using exemestane and celecoxib is temporarily closed to accrual and is undergoing re-evaluation due to new information about a possible relationship between celecoxib and increased risk of heart attacks, strokes, and deaths resulting from blood vessel disease. We are actively accruing to the exemestane alone arm. Postmenopausal women, defined in this study as women who have not had a menstrual period for at least 12 months or who have had both ovaries removed, who are at increased risk for developing invasive breast cancer may be eligible to participate. Candidates are screened with breast cancer risk assessment, medical history and physical examination, blood tests, review of medical records, if needed, breast biopsy (surgical removal of a small sample of breast tissue for examination), and dual energy x-ray absorptionometry (DEXA) scan to assess bone density. For the DEXA scan, the subject lies still on a table for about 30 minutes while the spine and hip are scanned using a small amount of radiation. Participants take exemestane in pill form once a day for 5 years. They also take calcium and vitamin D pills daily to help protect bone health. They are followed in the clinic during the course of the study to determine the amount of drug taken and any side effects, and for the following tests and procedures: -Medical evaluation and blood tests at after 1 and 3 months on study drugs -Medical evaluation at 6 months -Breast biopsy at screening and then at 12 months -DEXA scan of the spine, mammogram and routine blood tests before starting study drugs and then yearly for 5 years -Breast examination, review of side effects, and refill of study drugs every 6 months for 5 years -Quality of life questionnaire before starting study drugs and after 1 year and 5 years on study drugs
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