A Phase II study of vinorelbine plus Gemcitabine Combination Chemotherapy in Patients with taxans refractory advanced or metastatic Breast Cancer
Phase 2
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000004839
- Lead Sponsor
- Kinki Multidisciplinary Breast Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 42
Inclusion Criteria
Not provided
Exclusion Criteria
1) Pulmonary fibrosis or pneumonia 2) body cavity fluid whichi needs to be treated 3)Symptomatic brain metastasis 4) Active double cancer 5) The diabetes that is impossible of control and high blood pressure case 6)HBs antigen positive 7)Heart diseases with the following items History of myocardial infarction ,unstable angina,post status of PTCA or CABG occurred within past 6 months Congestive heart failure Arrhythmia which needed to be treated 8)Apparently/possibly during pregnancy or lactation expectant 9) Serious drug allergy 10) Judged by the investigator to be unfit to be enrolled into the study
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, Overall survival, Time to treatment failure, Safety profiles