Studying Tumor Tissue Samples to Learn More About DNA Changes and Response in Patients With Breast Cancer Treated With Bevacizumab on Clinical Trial ECOG-2100

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00899418
• Lead Sponsor: Eastern Cooperative Oncology Group

Brief Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This laboratory study is examining tumor tissue samples from patients with breast cancer treated with bevacizumab on clinical trial ECOG-2100 to learn more about DNA changes and response in these patients.

Detailed Description

OBJECTIVES:

Primary

* Assess the effect of known variant polymorphisms (with functionally important associations) of the vascular endothelial growth factor (VEGF) gene on outcome (time to progression) in patients with breast cancer treated with bevacizumab on clinical trial ECOG-2100.

Secondary

* Assess the effect of known variant polymorphisms (with functionally important associations) of the VEGF receptor-2 (KDR) gene on outcome (time to progression) in these patients.

* Assess the effect of known variant polymorphisms of these genes on efficacy (objective response rate and survival) in these patients.

* Assess the effect of known variant polymorphisms of these genes on toxicity outcome in these patients.

* Assess the effect of VEGF polymorphisms on VEGF expression by immunohistochemical staining (a known prognostic marker).

* Assess the effect of KDR polymorphisms on KDR expression by immunohistochemical staining.

OUTLINE: This is a multicenter study.

Tissue and genomic DNA samples from paraffin-embedded primary tumor are examined using standard polymerase chain reaction (PCR) restriction fragment-length polymorphisms, immunohistochemistry, allele-specific PCR, and/or Taqman-based assays. Vascular endothelial growth factor (VEGF) and VEGF receptor-2 (KDR) expression and polymorphisms are assessed.

PROJECTED ACCRUAL: A total of 500 specimens will be accrued for this study.

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2006-11
• Status Verified: 2008-10
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Last Update Submitted: 2013-04-02
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to progression in patients with a known polymorphism vs those with wild-type vascular endothelial growth factor (VEGF) gene

Secondary Outcome Measures

Name	Time	Method
Time to progression in patients with a known polymorphism vs those with wild-type VEGF receptor-2 (KDR) gene
Difference in response rate, survival, and toxicity in patients with a known polymorphism vs wild-type VEGF and KDR