A Phase III Randomized Study for HER2-Overexpressed Metastatic Breast Cancer Patients Treated by Trastuzumab( Cipterbin®) Plus vinorelbinE Simultaneously or Sequencely
Phase 3
18 Years
70 Years
18 Years
70 Years
Not Enrolling
Both
Progress-free Survival, Overall Response Rate, Adverse Events
Both
Progress-free Survival, Overall Response Rate, Adverse Events
Trial Information
A Phase III Randomized Study for HER2-Overexpressed Metastatic Breast Cancer Patients Treated by Trastuzumab( Cipterbin®) Plus vinorelbinE Simultaneously or Sequencely
Inclusion Criteria:
- signed ICF
- pathologic diagnosis breast cancer
- HER2+ status defined as IHC3+ Staining or in situ hybridization positive at least 1
measurable lesion as per RECIST criteria age from 18y to 70y KPS>=70
Exclusion Criteria:
- More than three prior chemotherapy lines for advanced disease LVEF<50%
- prior exposure vinorebine for breast cancer
- prior exposure Trastuzumab for breast cancer
- uncontrolled brain metastasis
- breastfeeding or pregnant
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Outcome Measure:
progress-free survival
Authority:
China: Food and Drug Administration
Study ID:
HOPES
NCT ID:
NCT01291667
Start Date:
May 2009
Completion Date:
Related Keywords:
- Progress-free Survival
- Overall Response Rate
- Adverse Events
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