Randomized Phase II Study on the Additive Effect of Everolimus in Post-Menopausal Patients with Endocrine Therapy-Sensitive ER-Positive HER2-Negative Metastatic Breast Cancer
Not Applicable
Recruiting
- Conditions
- Metastatic breast cancer
- Registration Number
- JPRN-UMIN000025156
- Lead Sponsor
- CSPOR-BC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 130
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who have active double cancer Patients who have a history of serious drug hypersensitivity. Patients who have serious concomitant diseases. Patients who have an active infectious disease requiring systemic treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression-free survival, PFS
- Secondary Outcome Measures
Name Time Method overall survival(OS), response rate (RR), disease control rate (DCR), safety , time to treatment failure (TTF) , the proportion of patients who continued administration of AI agents for 1 year after the randomized allocation