Breast Cancer
Conditions
Keywords
Breast cancer, Tyrosine inhibitor, Chemotherapy, Imatinib
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
Interventions
DRUGImatinib and Vinorelbine
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (MTD) | at least 28 days |
Countries
Germany
Outcome results
None listed