Clinical trial · Interventional
Efficacy and Safety of Imatinib and Vinorelbine in Patients With Advanced Breast Cancer
Open-label Trial of Imatinib in Combination With Vinorelbine for Patients With Advanced Breast Carcinoma: ICON
NCT00372476CI-TRIAL-00025824INV181completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib and Vinorelbine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imatinib + Vinorelbine
- interventionNames
- Drug: Imatinib and Vinorelbine
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- at least 28 days
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTMaass N, Schem C, Bauerschlag DO, Tiemann K, Schaefer FW, Hanson S, Muth M, Baier M, Weigel MT, Wenners AS, Alkatout I, Bauer M, Jonat W, Mundhenke C. Final safety and efficacy analysis of a phase I/II trial with imatinib and vinorelbine for patients with metastatic breast cancer. Oncology. 2014;87(5):300-10. doi: 10.1159/000365553. Epub 2014 Aug 26. PMID 25171229