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)

NCT01439191 Phase 2 COMPLETED

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.

Details

Lead sponsor	Shanghai CP Guojian Pharmaceutical Co., Ltd.
Phase	Phase 2
Status	COMPLETED
Enrolment	109
Start date	2005-07
Completion	2007-05

Conditions

• Metastatic Breast Cancer

Interventions

• humanized anti-HER2 antibody
• Vinorelbine

Primary outcomes

• Overall response rate — up to 24 weeks
  according to RECIST 1.0 (Response Evaluation Criteria In Solid Tumors)

Countries

China