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

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ClinicalTrials.gov Identifier: NCT01439191
Recruitment Status : Completed
First Posted : September 23, 2011
Last Update Posted : September 23, 2011
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: humanized anti-HER2 antibody Drug: Vinorelbine Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Randomized Phase II Study of Cipterbin® or Cipterbin® in Combination With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer (MBC)
Study Start Date : July 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: combination agent group 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.
Other Name: brand name:Cipterbin®

Drug: Vinorelbine
Vinorelbine was administered weekly at a dose of 25 mg/m2 on day 1, 8 and 21 every 4 weeks
Other Name: brand name:NAVELBINE®

Experimental: single agent group
In this arm, patients would be treated with Cipterbin® for 12 or 24 weeks
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.
Other Name: brand name:Cipterbin®




Primary Outcome Measures :
  1. Overall response rate [ Time Frame: up to 24 weeks ]
    according to RECIST 1.0 (Response Evaluation Criteria In Solid Tumors)


Secondary Outcome Measures :
  1. One-year survival rate [ Time Frame: 1 year ]
  2. Number of participants with adverse events [ Time Frame: up to 24 weeks ]
    Adverse events was recorded according to NCI CTC 2.0 (National Cancer Institute common toxicity criteria).

  3. Overall control of disease [ Time Frame: up to 24 weeks ]
    defined as overall response rate plus stable disease, by RECIST 1.0



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439191


Locations
China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Sponsors and Collaborators
Shanghai CP Guojian Pharmaceutical Co.,Ltd.
Investigators
Study Chair: Yan Sun, PhD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Director: Yuankai Shi, PhD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Principal Investigator: Zefei Jiang, PhD Hospital Affiliated to Academy Military Medical Science
Principal Investigator: Jun Ren, PhD Beijing Cancer Hospital
Principal Investigator: Xichun Hu, PhD Fudan University
Principal Investigator: Kai Li, PhD Tianjin Medical University Cancer Institute and Hospital
Principal Investigator: Dong Wang, PhD Daping Hospital & Research Institute of Surgery of the Third Military Medical University

Responsible Party: Shanghai CP Guojian Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01439191     History of Changes
Other Study ID Numbers: C302MBCⅡ
First Posted: September 23, 2011    Key Record Dates
Last Update Posted: September 23, 2011
Last Verified: June 2005

Keywords provided by Shanghai CP Guojian Pharmaceutical Co.,Ltd.:
HER2-Overexpressed

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Antibodies
Vinorelbine
Vinblastine
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action