Study of Cipterbin®, Used Alone or With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer

NCT ID: NCT01439191

Last Updated: 2011-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2007-05-31

Brief Summary

The HER2 gene (also known as HER2/neu and ErbB2 gene) is overexpressed in 20-30% of human breast cancers and leads to a particularly aggressive form of the disease. Trastuzumab,a humanized anti-HER2/neu receptor monoclonal antibody, has been proved a valuable treatment for HER2-positive breast cancer patients.The combination of trastuzumab with chemotherapy has been shown to increase both survival and response rate, in comparison to trastuzumab alone. CMAB302, a biosimilar of trastuzumab, was developed by Shanghai CP Guojian Pharmaceutical Co.Ltd. Efficacy and safety of CMAB302 as a single agent or in combination with vinorelbine were evaluated in patients with HER2-overexpressing metastatic breast cancer.

Detailed Description

The HER2 gene (also known as HER2/neu and ErbB2 gene) is overexpressed in 20-30% of human breast cancers and leads to a particularly aggressive form of the disease. Trastuzumab,a humanized anti-HER2/neu receptor monoclonal antibody, has been proved valuable treatment for HER2-positive breast cancer patients.The combination of trastuzumab with chemotherapy has been shown to increase both survival and response rate, in comparison to trastuzumab alone. CMAB302, a biosimilar of trastuzumab, was developed by Shanghai CP Guojian Pharmaceutical Co.Ltd. Previous Phase I study showed that CMAB302 was well tolerated as monotherapy and the pharmacokinetic data exhibited a non-linear profile over the dose range of 100 to 500 mg, similar to that of trastuzumab. In this study, efficacy and safety of CMAB302 as a single agent or in combination with vinorelbine were evaluated in patients with HER2-overexpressing metastatic breast cancer.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

combination agent group

Group Type: EXPERIMENTAL

humanized anti-HER2 antibody

Intervention Type: DRUG

Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly for 12 weeks. For single agent group, patients with complete response, partial response or stable disease could be treated for 24 weeks.

Vinorelbine

Intervention Type: DRUG

Vinorelbine was administered weekly at a dose of 25 mg/m2 on day 1, 8 and 21 every 4 weeks

single agent group

In this arm, patients would be treated with Cipterbin® for 12 or 24 weeks

Group Type: EXPERIMENTAL

humanized anti-HER2 antibody

Intervention Type: DRUG

Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly for 12 weeks. For single agent group, patients with complete response, partial response or stable disease could be treated for 24 weeks.

Interventions

humanized anti-HER2 antibody

Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly for 12 weeks. For single agent group, patients with complete response, partial response or stable disease could be treated for 24 weeks.

Intervention Type: DRUG

Vinorelbine

Vinorelbine was administered weekly at a dose of 25 mg/m2 on day 1, 8 and 21 every 4 weeks

Intervention Type: DRUG

Other Intervention Names

brand name:Cipterbin®; brand name:NAVELBINE®

Eligibility Criteria

Inclusion Criteria

• pathologic diagnosis breast cancer
• HER2+ status defined as IHC3+ Staining or in situ hybridization positive at least 1 measurable lesion as per RECIST criteria
• Adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
• Adequate liver (bilirubin <1.0 times upper limit of normal and SGOT/SGPT <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
• Adequate cardiac function (LVEF>50%). Normal electrocardiogram and absence of significant heart disease
• age from 18 to 70y
• Karnofsky performance score ≥ 60
• Life expectancy of greater than 3 months
• Negative HCG pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause.
• signed ICF

Exclusion Criteria

• prior exposure vinorelbine for breast cancer
• prior exposure trastuzumab for breast cancer
• Prior chemotherapy and radiation therapy within the last 4 weeks before enrollment
• use of any other investigational agents within the last 4 weeks before enrollment
• symptomatic, central nervous system metastases
• Hypersensitivity to trial medications
• 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

Responsibility Role: SPONSOR

Principal Investigators

Yan Sun, PhD

Role: STUDY_CHAIR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Yuankai Shi, PhD

Role: STUDY_DIRECTOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Zefei Jiang, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Affiliated to Academy Military Medical Science

Jun Ren, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Xichun Hu, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Kai Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Dong Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Daping Hospital & Research Institute of Surgery of the Third Military Medical University

Locations

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Countries

China

Other Identifiers

C302MBCⅡ

Identifier Type: -

Identifier Source: org_study_id