Biomarkers in Tissue Samples From Patients With Breast Cancer Treated With Bevacizumab
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.
|Breast Cancer||Genetic: DNA analysis Genetic: gene expression analysis Genetic: polymorphism analysis Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis|
|Study Design:||Observational Model: Other
Time Perspective: Retrospective
|Official Title:||VEGF Gene Amplification/Deletion and Haplotype as Biomarkers for Bevacizumab in Breast Cancer|
- Comparison between VEGF haplotype and median overall survival (OS) and grade 3/4 hypertension (HTN) [ Time Frame: 1 month ]
- Comparison between VEGF amplification/deletion and VEGF expression [ Time Frame: 1 month ]
|Actual Study Start Date:||April 5, 2011|
|Study Completion Date:||September 8, 2011|
|Primary Completion Date:||September 8, 2011 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156168
|Principal Investigator:||Bryan P. Schneider, MD||Indiana University Melvin and Bren Simon Cancer Center|