Status:
COMPLETED
Efficacy and Safety of Imatinib and Vinorelbine in Patients With Advanced Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
This study is designed to investigate the safety and efficacy of the combination of imatinib and vinorelbine in patients with advanced, anthracycline resistant breast cancer
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Histologically documented diagnosis of invasive breast cancer that is locally advanced or metastatic
- Previous anthracycline containing chemotherapy
- Presence of a certain protein on the cell surface (c-kit (CD117) and /or PDGF-receptor)
- Preferably tumor samples should be taken within 6 weeks of study entry. Most recent primary tumor tissue has to be available for analysis
- Acceptable health status (Eastern Cooperative Oncology Group \[ECOG\]-performance status 0,1, 2 or 3)
- Exclusion criteria: (for the second-line therapy)
- Patient with Grade III/IV cardiac problems (i.e., congestive heart failure, myocardial infarction within 6 months of study) and with severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
- Patient has a known brain metastasis, chronic liver disease (i.e., chronic active hepatitis, and cirrhosis) and diagnosis of (HIV) infection.
- Patient received chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing.
- Patient previously received radiotherapy to ≥ 25 % of the bone marrow and had a major surgery within 2 weeks prior to study entry.
- Patient received either Vinorelbine or Imatinib in previous treatment regimens
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00372476
Start Date
June 1 2006
End Date
July 1 2012
Last Update
February 7 2017
Active Locations (1)
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1
Novartis Investigative Site
Kiel, Germany, 24105