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

Completed

• Conditions: Progress-free Survival; Overall Response Rate; Adverse Events

• Registration Number: NCT01291667
• Lead Sponsor: Shanghai CP Guojian Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Status Verified: 2011-02
• Study First Submitted: 2011-02-06
• Study First Submitted QC: 2011-02-07
• Last Update Submitted: 2011-02-07
• Study First Posted: 2011-02-08
• Last Update Posted: 2011-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progress-free survival

Secondary Outcome Measures

Name	Time	Method
overall response rate,safety