Open-label Trial of Imatinib in Combination With Vinorelbine for Patients With Advanced Breast Carcinoma: ICON
- 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
- 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
- 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