Status:
COMPLETED
Study of Cipterbin®, Used Alone or With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer
Lead Sponsor:
Shanghai CP Guojian Pharmaceutical Co., Ltd.
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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/n...
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/n...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT01439191
Start Date
July 1 2005
End Date
May 1 2007
Last Update
September 23 2011
Active Locations (1)
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1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021