NSABP- B33

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 目前，原发性乳腺癌患者表现出雌激素受体，接受五年的抗雌激素治疗与他莫昔芬。 这是多年来的标准护理。 没有数据支持使用他莫昔芬超过五年，事实上，至少有一项研究显示使用他莫昔芬超过五年的结果更糟。 除了密切观察外，没有向患者提供其他治疗。 依西美坦是一种新型芳香酶抑制剂，即干扰类固醇激素代谢的药物。 这项随机、安慰剂对照、双盲临床试验的主要目的是确定绝经后雌激素受体阳性（ER+）和/或孕酮受体阳性（PgR+）乳腺癌患者口服阿司美坦2年是否（CT 1-3 cNO-1 MO），与安慰剂相比，已完成5年他莫昔芬治疗的患者将延长无病生存期和总生存期。 要符合条件，患者必须完成约5年的辅助他莫昔芬治疗（10 mg po每日2次或20 mg po每日），无疾病，并已通过乳房肿瘤切除术和腋窝淋巴结清扫术或改良根治性乳房切除术切除。 符合条件的患者可能在诊断乳腺癌时接受过辅助或新辅助化疗。 按照淋巴结状态分层后，患者将随机接受维美坦25 mg po/d或安慰剂治疗2年。 本研究的另一个目的是评估他莫昔芬停药对骨骼的影响，并确定依西美坦是否对他莫昔芬停药引起的骨质流失率有任何额外影响。 将收集整个研究人群的骨折、身高和血清总碱性磷酸酶数据。

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.