Study for HER2-Overexpressed MBC Patients Treated by Cipterbin® Plus vinorelbinE

A Phase III Randomized Study for HER2-Overexpressed Metastatic Breast Cancer Patients Treated by Trastuzumab( Cipterbin®) Plus vinorelbinE Simultaneously or Sequencely

Breast cancer is the most common malignant disease and the most frequent causes of cancer mortality in females worldwide. The situation is same as the world in China. Trastuzumab has been proved valuable treatment for HER2-positive breast cancer patients. Cipterbin® is developing by Shanghai CP Guojian Pharmaceutical Co.Ltd.Now we carried on the phase III trial in order to prove Cipterbin® 's efficacy and safety.

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