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

Shanghai CP Guojian Pharmaceutical Co., Ltd.330 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

330

Conditions

Progress-free Survival Overall Response Rate Adverse Events

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

progress-free survival

Secondary Outcomes

overall response rate,safety

Data from ClinicalTrials.gov

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