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.
Original language | English |
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Pages (from-to) | 13-18 |
Number of pages | 6 |
Journal | Open Access Journal of Clinical Trials |
Volume | 10 |
DOIs | |
Publication status | Published - Feb 16 2018 |
Keywords
- Aromatase inhibitor
- Breast cancer
- Everolimus
- Hormone receptor-positive
ASJC Scopus subject areas
- Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
- Pharmacology (medical)