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

NCT01439191 | Completed Phase 2 DMC

• 1 other identifier: C302MBCⅡ
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Keywords

HER2-Overexpressed

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  according to RECIST 1.0 (Response Evaluation Criteria In Solid Tumors)

  up to 24 weeks

Secondary Outcomes (3)

• One-year survival rate

  1 year

• Number of participants with adverse events

  up to 24 weeks

• Overall control of disease

  up to 24 weeks

Study Arms (2)

combination agent group

EXPERIMENTAL

Drug: humanized anti-HER2 antibody; Drug: Vinorelbine

single agent group

EXPERIMENTAL

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

Drug: humanized anti-HER2 antibody

Interventions

humanized anti-HER2 antibody 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.

Also known as: brand name:Cipterbin®

combination agent group; single agent group

Vinorelbine DRUG

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

Also known as: brand name:NAVELBINE®

combination agent group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai CP Guojian Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Yan Sun, PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

• Yuankai Shi, PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY DIRECTOR

• Zefei Jiang, PhD

  Hospital Affiliated to Academy Military Medical Science

  PRINCIPAL INVESTIGATOR

• Jun Ren, PhD

  Peking University Cancer Hospital & Institute

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 23, 2011
• Study Start: July 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: May 1, 2007
• Last Updated: September 23, 2011

Record last verified: 2005-06

Locations

CN (1)