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

Tatsunori Shimoi, Akihiko Shimomura, Tadahiko Shien, Yukari Uemura, Hiroaki Kato, Masahiro Kitada, Tatsuya Toyama, Tomohiko Aihara, Hirofumi Mukai

Research output: Contribution to journalArticle


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.

Original languageEnglish
Pages (from-to)13-18
Number of pages6
JournalOpen Access Journal of Clinical Trials
Publication statusPublished - Feb 16 2018



  • Aromatase inhibitor
  • Breast cancer
  • Everolimus
  • Hormone receptor-positive

ASJC Scopus subject areas

  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
  • Pharmacology (medical)

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