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

NCT ID: NCT00372476

Last Updated: 2017-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2012-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Imatinib + Vinorelbine

Group Type EXPERIMENTAL

Imatinib and Vinorelbine

Intervention Type DRUG

Interventions

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Imatinib and Vinorelbine

Intervention Type DRUG

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmeceuticals

Locations

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Novartis Investigative Site

Kiel, , Germany

Site Status

Countries

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Germany

References

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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 metastatic breast cancer. Oncology. 2014;87(5):300-10. doi: 10.1159/000365553. Epub 2014 Aug 26.

Reference Type RESULT
PMID: 25171229 (View on PubMed)

Other Identifiers

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2005-001537-15

Identifier Type: -

Identifier Source: secondary_id

CSTI571BDE28

Identifier Type: -

Identifier Source: org_study_id

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