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

NCT ID: NCT01291667

Last Updated: 2011-02-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 330 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31

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.

Conditions

Progress-free Survival; Overall Response Rate; Adverse Events

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai CP Guojian Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Hospital Affiliated to Academy Military Medical Science

Other Identifiers

HOPES

Identifier Type: -

Identifier Source: org_study_id