NSABP B-35

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项第三阶段随机双盲研究将评估阿那曲唑与他莫昔芬在预防接受肿块切除和乳房放射治疗的绝经后原发导管原位癌(DCIS)妇女的乳腺癌(局部、区域和远处复发，以及对侧乳腺癌)后续发生方面的有效性。此外，这项研究还将在浸润性乳腺癌、同侧复发、对侧乳腺癌、其他非乳腺第二原发癌、骨质疏松性骨折、无病存活率和总存活率方面比较阿那曲唑和他莫昔芬在时间上的差异。此外，B-35将确定与他莫昔芬相比，阿那曲唑对患者症状和生活质量的影响。分析将包括基于生存时间的终点，根据所经历的生活质量进行调整。

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. This Phase III randomized, double-blind study will evaluate the effectiveness of anastrozole compared to tamoxifen in preventing the subsequent occurrence of breast cancer (local, regional and distant recurrences, and contralateral breast cancer) in postmenopausal women with primary ductal carcinoma in situ (DCIS) treated with lumpectomy and breast radiation. In addition, this study will compare adjuvant anastrozole to tamoxifen in terms of time to invasive breast cancer, ipsilateral recurrence, contralateral breast cancer, other non-breast second primary cancers, osteoporotic fractures, disease-free survival, and overall survival. Also, B-35 will ascertain the effects of anastrozole on patients' symptoms and quality of life as compared to tamoxifen. Analysis will include an endpoint based on survival time adjusted for the quality of life experienced.