Phase II study of the combination of Eribulin and Trastuzumab Evaluating Efficacy and Safety in Patients with advanced/recurrent HER2-positive breast cancer.
Phase 2
Recruiting
- Conditions
- Advanced/recurrent HER2-positive breast cancer
- Registration Number
- JPRN-UMIN000011020
- Lead Sponsor
- Sairtama Breast Cancer Clinical Study Group (SBCCSG)na
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 35
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 Objective Response Rate
- Secondary Outcome Measures
Name Time Method Clinical Benefit Rate Overall Survival Progression Free Survival Time to Treament Failure Safety