NSABP- B33

NSABP-B33

• 批准号: 7607582
• 负责人: Scott Henry Kurtzman
• 金额: $ 0.03万
• 依托单位: UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7607582
• 关键词: Adjuvant; Alkaline Phosphatase; Aromatase Inhibitors; Axillary lymph node group; Caring; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Daily; Data; Disease; Disease-Free Survival; Dissection; Double-Blind Method; Estrogen Antagonists; Estrogen Receptors; Estrogen receptor positive; Exemestane; Fracture; Funding; Grant; Height; Institution; Modified radical mastectomy; National Surgical Adjuvant Breast and Bowel Project; Neoadjuvant Therapy; Nodal; Oral Administration; Patients; Pharmaceutical Preparations; Placebo Control; Placebos; Population Study; Postmenopause; Randomized; Rate; Research; Research Personnel; Resected; Resources; Serum; Source; Standards of Weights and Measures; Stratification; Tamoxifen; Time; United States National Institutes of Health; Withdrawal; bone; bone loss; breast cancer diagnosis; breast lumpectomy; chemotherapy; day; malignant breast neoplasm; progesterone receptor positive; steroid hormone metabolism

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Currently, patients whose primary breast cancer demonstrated estrogen receptors, receive five years of anti-estrogen treatment with tamoxifen. This has been standard care for many years. There is no data supporting more than five years of tamoxifen use, in fact at least one study showed worse results with more than five years of tamoxifen. There is no treatment offered to patients beyond this other than close observation. Exemestane is a new aromatase inhibitor, i.e. a drug that interferes with the metabolism of steroid hormones. The primary aim of this randomized, placebo-controlled, double-blind clinical trial is to determine whether oral administration of exemestane, for 2 years, in postmenopausal patients with estrogen-receptor-positive (ER+) and/or progesterone-receptor-positive (PgR+) breast cancer (CT 1-3 cNO-1 MO) who have completed 5 years of tamoxifen therapy, will prolong disease-free survival and overall survival when compared with placebo. To be eligible, patients must have completed approximately 5 years of adjuvant tamoxifen therapy (either 10 mg po twice a day or 20 mg po daily), be disease free, and have been resected by lumpectomy and axillary node dissection or by modified radical mastectomy. Eligible patients may have received either adjuvant or neoadjuvant chemotherapy at the time of their breast cancer diagnosis. Following stratification by nodal status, patients will be randomized to receive either exemestane 25 mg po daily or placebo, for 2 years. Another aim of this study is to evaluate the effect of tamoxifen withdrawal on bone and to determine if exemestane has any additional effects on the rate of bone loss resulting from tamoxifen withdrawal. Data for fractures, height, and total serum alkaline phosphatase will be collected on the entire study population.

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