Open-label Phase II study of everolimus plus endocrine therapy in postmenopausal women with ER-positive and HER2-negative metastatic breast cancer (Chloe trial)

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
T. Shimoi, A. Shimomura, T. Shien, Y. Uemura, H. Kato, M. Kitada, T. Toyama, T. Aihara, H. Mukai
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引用次数: 1

Abstract

Background: This is a randomized, multicenter, open-label, Phase II study designed to evaluate the efficacy of everolimus added to continuous aromatase inhibitor (AI) administration in patients who had maintained stable disease or a better response for at least 5 months. Patients and methods: Patients will be randomized to everolimus and standard therapy groups (1:1 ratio). In the everolimus group, patients will receive everolimus in addition to the AI agent. The standard therapy group will continue AI alone treatment. The primary endpoint is progression-free survival. Target accrual is 130 patients with a two-sided type I error rate of 10% and 80% power to detect 35% risk reduction. Conclusion: The Chloe trial will provide important information about the efficacy and safety of adding everolimus to AI in patients with estrogen receptor-positive and human epidermal growth factor 2-negative metastatic breast cancer.
依维莫司联合内分泌治疗绝经后er阳性和her2阴性转移性乳腺癌的开放标签II期研究(Chloe试验)
背景:这是一项随机、多中心、开放标签的II期研究,旨在评估依维莫司在芳香化酶抑制剂(AI)连续给药中对至少5个月病情稳定或反应较好的患者的疗效。患者和方法:将患者随机分为依维莫司和标准治疗组(1:1比例)。在依维莫司组中,除了AI制剂外,患者还将接受依维莫斯治疗。标准治疗组将继续进行AI单独治疗。主要终点是无进展生存期。目标累积为130名患者,双侧I型错误率为10%,检测风险降低35%的能力为80%。结论:Chloe试验将为在AI中加入依维莫司治疗雌激素受体阳性和人表皮生长因子2阴性转移性癌症的有效性和安全性提供重要信息。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Open Access Journal of Clinical Trials
Open Access Journal of Clinical Trials MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
3.90
自引率
0.00%
发文量
2
审稿时长
16 weeks
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