NCT01156168

Biomarkers in Tissue Samples From Patients With Breast Cancer Treated With Bevacizumab

VEGF Gene Amplification/Deletion and Haplotype as Biomarkers for Bevacizumab in Breast Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 363 (actual)
• Sponsor: ECOG-ACRIN Cancer Research Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment. PURPOSE: This research study is studying biomarkers in tissue samples from patients with breast cancer treated with bevacizumab.

Detailed description

OBJECTIVES: Primary * To demonstrate that vascular endothelial growth factor-A (VEGFA) haplotypes that are associated with an increased VEGFA expression will predict superior outcome for patients with metastatic breast cancer receiving bevacizumab in ECOG-E2100 (but not for the control arm). * To demonstrate that candidate single nucleotide polymorphisms (SNPs) will further improve the predictive capacity of outcome (efficacy and toxicity) in patients enrolled in ECOG-E2100. * To demonstrate that tumor VEGFA amplification or borderline amplification (estimated 14% frequency) will predict superior outcome for patients with metastatic breast cancer receiving bevacizumab on ECOG-E2100 whereas those with VEGFA deletion (estimated 11% frequency) will predict inferior outcome. * To demonstrate that VEGFA amplification/deletion will not predict outcome in the control arm of ECOG-E2100. Secondary * To demonstrate that tumor VEGFA amplification will predict increased protein expression as ascertained by IHC. * To demonstrate that a combined algorithm calculated from tumor-specific variability (VEGFA amplification/deletion) and host-specific variability (SNPs) will optimally predict outcome (efficacy) with bevacizumab in patients enrolled on ECOG-E2100. OUTLINE: This is a multicenter study. Previously collected tumor-derived DNA is analyzed for VEGFA amplification/deletion and haplotype as biomarkers for outcome after bevacizumab treatment. Gene expression, polymorphism, protein expression analysis, and IHC are performed on the samples.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
GENETIC	DNA analysis
GENETIC	gene expression analysis
GENETIC	polymorphism analysis
GENETIC	protein expression analysis
OTHER	immunohistochemistry staining method
OTHER	laboratory biomarker analysis

Timeline

• Start date: 2011-04-05
• Primary completion: 2011-09-08
• Completion: 2011-09-08
• First posted: 2010-07-02
• Last updated: 2017-05-17