Efficacy and Safety of Imatinib and Vinorelbine in Patients With Advanced Breast Cancer (INV181)

Novartis

Status and phase

Completed

Phase 4

Conditions

Breast Cancer

Treatments

Drug: Imatinib and Vinorelbine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00372476

2005-001537-15

CSTI571BDE28

Details and patient eligibility

About

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

Enrollment

33 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 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