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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Genetic: gene expression analysis
* Genetic: polymerase chain reaction
* Genetic: polymorphism analysis
* Other: immunohistochemistry staining method


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the breast Enrolled on clinical trial ECOG-2100 and received treatment with bevacizumab Paraffin-embedded tumor samples available Hormone receptor status not specified PATIENT CHARACTERISTICS: Female Menopausal status not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene expression analysis|nan|
|Genetic: polymerase chain reaction|nan|
|Genetic: polymorphism analysis|nan|
|Other: immunohistochemistry staining method|nan|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent breast cancer, stage IV breast cancer