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

Breast Cancer Clinical Trial

— INV181  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372476
• Other study ID #: CSTI571BDE28
• Secondary ID: 2005-001537-15
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2006
• Last updated: February 3, 2017
• Start date: June 2006
• Est. completion date: July 2012

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Imatinib and Vinorelbine

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Maass 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD)		at least 28 days

External Links

•   Results for CSTI571BDE28 from the Novartis Clinical Trials website