Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who presented well-defined taxane resistance
Phase 2
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000006965
- Lead Sponsor
- Saitama Breast Cancer Clinical Study Group (SBCCSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 52
Inclusion Criteria
Not provided
Exclusion Criteria
1)having systemic infection with a fever of 38 degrees or more 2)pleural effusion, ascites, or pericardial fluid requiring drainage 3)brain metastasis with clinical symptoms 4)patient with following serious complication ischaemic heart disease or heart disease such as arrhythmia not controllable by treatment myocardial infarction < 6 months prior to study entry hepatic cirrhosis interstitial pneumonia or pulmonary fibrosis bleeding tendency 5)having active double cancer 6)HER2 over-expressed 7)pregnancy, breast-feeding or women with childbearing potential 8)judged by the investigator not to be appropriate for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Benefit Rate
- Secondary Outcome Measures
Name Time Method EORTC QLQ-C30 Progression Free Survival Overall Survival Safety