NCT00899418

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
GENETIC	gene expression analysis
GENETIC	polymerase chain reaction
GENETIC	polymorphism analysis
OTHER	immunohistochemistry staining method

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-11-01
• First posted: 2009-05-12
• Last updated: 2013-04-04