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

NCT01439191 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2011-09-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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.

DRUG

Vinorelbine

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

Sponsors & Collaborators

  • Shanghai CP Guojian Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yan Sun, PhD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Yuankai Shi, PhD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Zefei Jiang, PhD · Hospital Affiliated to Academy Military Medical Science

  • Jun Ren, PhD · Peking University Cancer Hospital & Institute

  • Xichun Hu, PhD · Fudan University

  • Kai Li, PhD · Tianjin Medical University Cancer Institute and Hospital

  • Dong Wang, PhD · Daping Hospital & Research Institute of Surgery of the Third Military Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2007-02-28
Completion
2007-05-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01439191 on ClinicalTrials.gov