NSABP- B33

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。目前，原发性乳腺癌患者表现出雌激素受体，接受他莫昔芬为期五年的抗雌激素治疗。多年来，这一直是标准护理。没有数据支持他莫昔芬使用超过五年，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差。除此之外，除了密切观察，没有其他治疗方法可供患者使用。依西美坦是一种新的芳香酶抑制剂，即干扰类固醇激素代谢的药物。这项随机、安慰剂对照的双盲临床试验的主要目的是确定口服西美坦2年，与安慰剂相比，服用西美坦2年的绝经后雌激素受体阳性(ER+)和/或孕激素受体阳性(PGR+)乳腺癌(CT 1-3 CNO-1 MO)患者是否会与安慰剂相比延长无病生存期和总生存期。要符合条件，患者必须完成大约5年的三苯氧胺辅助治疗(每天两次10毫克或每天20毫克)，没有疾病，并接受过肿块切除和腋窝淋巴结清扫或改良的乳腺癌根治术。符合条件的患者在诊断乳腺癌时可能已经接受了辅助或新辅助化疗。在按结节状态分层后，患者将被随机分为两组，一组每天服用依西美坦25毫克，另一组服用安慰剂，为期两年。这项研究的另一个目的是评估他莫昔芬停药对骨骼的影响，并确定西美坦是否对因他莫昔芬停药而导致的骨丢失有任何额外的影响。将收集整个研究人群的骨折、身高和血清总碱性磷酸酶的数据。参加试验的216名患者将通过骨密度(BMD)和骨生化标记物的系列测量进行前瞻性评估。特定的NSABP部位将被要求参与这项骨矿密度(BBL)子研究(见附录A)。(康涅狄格州大学没有被选为参与BBL分研究的对象)。

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. A subgroup of 216 patients entered in the trial will be prospectively evaluated using serial measurements of both bone mineral density (BMD) and bone biochemical markers. Specific NSABP sites will be asked to participate in this bone mineral density (BBL) substudy (see Appendix A). (UConn was not chosen to participate in the BBL substudy).