Effect of Additional pertuzumab for the post treatment in Patients with HER2 positive locally advanced/ metastatic Breast Cancer Who Were Previously Treated with pertuzumab - Phase II study
Not Applicable
- Conditions
- breast cancer
- Registration Number
- JPRN-UMIN000020837
- Lead Sponsor
- Setouchi Breast Project Comprehensive Support Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1 pretreated with all of VNR, PTX and ERI 2 allergic for VNR, PTX, ERI, polyoxyethylene castor oil, CHO or recombinant humanized monoclonal antibody 3 symptomatic brain metastasis 4 pregnancy or breast feeding or unwilling to contraception 5 uncontrolled hypertension, symptomatic heart failure, unstable angina, severe arrhythmia or acute myocardial infarction within 12 months 6 obvious pulmonary fibrosis or interstitial pneumonia 7 EF <50% 8 active infection 9 no other severe comorbidity 10 no another active cancer 11 other inappropriate patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method clinical benefit rate
- Secondary Outcome Measures
Name Time Method PFS, OS, response rate, response rate of the initial therapy, safety