Clinical trial NCT01439191: Study of Cipterbin®, Used Alone or With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: HER2-Overexpressed
Lead sponsor: Shanghai CP Guojian Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-09-23
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Overall response rate
timeFrame: up to 24 weeks
Secondary outcomes:
measure: One-year survival rate
timeFrame: 1 year
measure: Number of participants with adverse events
timeFrame: up to 24 weeks
measure: Overall control of disease
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Yan Sun, PhD
role: STUDY_CHAIR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Yuankai Shi, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Affiliated to Academy Military Medical Science
name: Zefei Jiang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Cancer Hospital & Institute
name: Jun Ren, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Xichun Hu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Kai Li, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Daping Hospital & Research Institute of Surgery of the Third Military Medical University
name: Dong Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: