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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shanghai CP Guojian Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01439191
First received: September 21, 2011
Last updated: NA
Last verified: June 2005
History: No changes posted
  Purpose

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 Intervention Phase
Metastatic Breast Cancer
Drug: humanized anti-HER2 antibody
Drug: Vinorelbine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Shanghai CP Guojian Pharmaceutical Co.,Ltd.:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    according to RECIST 1.0 (Response Evaluation Criteria In Solid Tumors)


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

  • Overall control of disease [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    defined as overall response rate plus stable disease, by RECIST 1.0


Enrollment: 109
Study Start Date: July 2005
Study Completion Date: May 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Shanghai CP Guojian Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01439191     History of Changes
Other Study ID Numbers: C302MBCⅡ
Study First Received: September 21, 2011
Last Updated: September 21, 2011
Health Authority: China: Food and Drug Administration

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
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014