Spots Global Cancer Trial Database for Study of Cipterbin®, Used Alone or With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer
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Trial Identification
Brief Title: 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 ID: NCT01439191
Conditions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, , China
Contact Details
Name: Yan Sun, PhD
Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Role: STUDY_CHAIR
Name: Yuankai Shi, PhD
Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Role: STUDY_DIRECTOR
Name: Zefei Jiang, PhD
Affiliation: Hospital Affiliated to Academy Military Medical Science
Role: PRINCIPAL_INVESTIGATOR
Name: Jun Ren, PhD
Affiliation: Peking University Cancer Hospital & Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Xichun Hu, PhD
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
Name: Kai Li, PhD
Affiliation: Tianjin Medical University Cancer Institute and Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Dong Wang, PhD
Affiliation: Daping Hospital & Research Institute of Surgery of the Third Military Medical University
Role: PRINCIPAL_INVESTIGATOR
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