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

Shanghai CP Guojian Pharmaceutical

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01291667

HOPES

Details and patient eligibility

About

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.

Enrollment: 330 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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