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Tatsunori Shimoi,1 Akihiko Shimomura,1 Tadahiko Shien,2 Yukari Uemura,3 Hiroaki Kato,4 Masahiro Kitada,5 Tatsuya Toyama,6 Tomohiko Aihara,7 Hirofumi Mukai8 1Department of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan; 2Department of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan; 3Division of Biostatistics, Clinical Research Support Center, Tokyo University Hospital, Tokyo, Japan; 4Department of Thoracic Surgery, Teine Keijinkai Hospital, Sapporo, Japan; 5Department of Surgery, Asahikawa Medical University, Asahikawa, Japan; 6Department of Oncology, Immunology and Surgery, Nagoya City University, Graduate School of Medical Science, Nagoya, Japan; 7Department of Breast Surgery, Keimeikai-Aihara Hospital, Osaka, Japan; 8Department of Breast and Medical Oncology, National Cancer Center Hospital East, Chiba, Japan 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. Keywords: hormone receptor-positive, breast cancer, aromatase inhibitor, everolimus |
