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

NCT01291667 | Completed DMC

• 1 other identifier: HOPES
• Study Type: observational
• Target: 330
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• progress-free survival

Secondary Outcomes (1)

• overall response rate,safety

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HER2-positive metastatic breast cancer patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai CP Guojian Pharmaceutical Co., Ltd.: lead

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 6, 2011
• First Posted: February 8, 2011
• Study Start: May 1, 2009
• Last Updated: February 8, 2011

Record last verified: 2011-02