First-line Trastuzumab monotherapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study
Phase 2
- Conditions
- breast cancer
- Registration Number
- JPRN-C000000263
- Lead Sponsor
- H/D study group on Breast Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
Documented history of serious hypersensitivity reaction on the medical drugs Severe complication Fever, suspicious of infection Severe pleural fluid and pericardial effusion Symptomatic brain metastasis Active double cancer Interstitial pneumonia or pulmonary fibrosis Neuropathy Grade 2,3 or 4 edema Pregnant or lactating women Doctor' s decision for exclusion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method Progression-free survival(PFS) Overall survival(OS) adverse event(AE)