Jonat Walter, Mundhenke Christoph
Klinik für Gynäkologie und Geburtshilfe, Universitätsklinikum S-H, Campus Kiel, Germany.
Cancer Invest. 2007 Feb;25(1):14-8. doi: 10.1080/07357900701226990.
The adjuvant Femara versus Anastrozole Clinical Evaluation (FACE) trial compares upfront therapy letrozole 2.5 mg with anastrozole 1 mg daily for up to 5 years in postmenopausal, hormone receptor-positive, node-positive breast cancer patients. This phase III b open label, randomized, multicenter study will include 4000. patients from up to 250 international sites. Patients will be stratified by degree of lymph node involvement and HER-2 status. Any efficacy and safety difference of the two drugs will be reported. Primary objective is DFS, secondary objectives are safety, OS, time to distant metastases, time to contralateral breast cancer and breast cancer specific survival.
辅助来曲唑与阿那曲唑临床评估(FACE)试验比较了绝经后、激素受体阳性、淋巴结阳性乳腺癌患者使用2.5毫克来曲唑与1毫克阿那曲唑每日一次的初始治疗,最长持续5年。这项III期b开放标签、随机、多中心研究将纳入来自多达250个国际研究点的4000名患者。患者将按淋巴结受累程度和HER-2状态进行分层。将报告两种药物在疗效和安全性方面的任何差异。主要终点是无病生存期,次要终点是安全性、总生存期、远处转移时间、对侧乳腺癌发生时间和乳腺癌特异性生存期。