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

Metastatic Breast Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439191
• Other study ID #: C302MBC?
• Status: Completed
• Phase: Phase 2
• First received: September 21, 2011
• Last updated: September 21, 2011
• Start date: July 2005
• Est. completion date: May 2007

Study information

• Verified date: June 2005
• Source: Shanghai CP Guojian Pharmaceutical Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: May 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai CP Guojian Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate	according to RECIST 1.0 (Response Evaluation Criteria In Solid Tumors)	up to 24 weeks	No
Secondary	One-year survival rate		1 year	Yes
Secondary	Number of participants with adverse events	Adverse events was recorded according to NCI CTC 2.0 (National Cancer Institute common toxicity criteria).	up to 24 weeks	Yes
Secondary	Overall control of disease	defined as overall response rate plus stable disease, by RECIST 1.0	up to 24 weeks	No