Efficacy and Safety of Imatinib and Vinorelbine in Patients With Advanced Breast Cancer (INV181)
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ClinicalTrials.gov Identifier: NCT00372476 |
Recruitment Status :
Completed
First Posted : September 7, 2006
Last Update Posted : February 7, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: Imatinib and Vinorelbine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open-label Trial of Imatinib in Combination With Vinorelbine for Patients With Advanced Breast Carcinoma: ICON |
Study Start Date : | June 2006 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | July 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Imatinib + Vinorelbine |
Drug: Imatinib and Vinorelbine |
- Maximum tolerated dose (MTD) [ Time Frame: at least 28 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts 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/exclusion criteria may apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372476
Germany | |
Novartis Investigative Site | |
Kiel, Germany, 24105 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals | |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmeceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00372476 |
Other Study ID Numbers: |
CSTI571BDE28 2005-001537-15 |
First Posted: | September 7, 2006 Key Record Dates |
Last Update Posted: | February 7, 2017 |
Last Verified: | February 2017 |
Breast cancer Tyrosine inhibitor Chemotherapy Imatinib |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Imatinib Mesylate Vinorelbine Antineoplastic Agents |
Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |