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

Phase 4
18 Years
Not Enrolling
Breast Cancer

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Trial Information

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

Inclusion Criteria

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD)

Outcome Time Frame:

at least 28 days

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

June 2006

Completion Date:

July 2012

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Tyrosine inhibitor
  • Chemotherapy
  • Imatinib
  • Breast Neoplasms