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Clinical Trials/NCT00899418
NCT00899418
Completed
Not Applicable

Differential Response of Breast Cancer Patients on E2100 Treated With Bevacizumab as a Function of Genetic Polymorphisms of VEGF and KDR

Eastern Cooperative Oncology Group0 sites500 target enrollmentMay 2006
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Eastern Cooperative Oncology Group
Enrollment
500
Primary Endpoint
Time to progression in patients with a known polymorphism vs those with wild-type vascular endothelial growth factor (VEGF) gene
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2006
End Date
November 2006
Last Updated
13 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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

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