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

Phase 2

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: humanized anti-HER2 antibody; Drug: Vinorelbine

• Registration Number: NCT01439191
• Lead Sponsor: Shanghai CP Guojian Pharmaceutical Co., Ltd.

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.

Study Timeline

• Status Verified: 2005-06
• Study Start: 2005-07
• Primary Completion: 2007-02
• Study Completion: 2007-05
• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-21
• Last Update Submitted: 2011-09-21
• Study First Posted: 2011-09-23
• Last Update Posted: 2011-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combination agent group	humanized anti-HER2 antibody	-
single agent group	humanized anti-HER2 antibody	In this arm, patients would be treated with Cipterbin® for 12 or 24 weeks
combination agent group	Vinorelbine	-

Primary Outcome Measures

Name	Time	Method
Overall response rate	up to 24 weeks	according to RECIST 1.0 (Response Evaluation Criteria In Solid Tumors)

Secondary Outcome Measures

Name	Time	Method
One-year survival rate	1 year
Number of participants with adverse events	up to 24 weeks	Adverse events was recorded according to NCI CTC 2.0 (National Cancer Institute common toxicity criteria).
Overall control of disease	up to 24 weeks	defined as overall response rate plus stable disease, by RECIST 1.0

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China