Biomarkers in Tissue Samples From Patients With Breast Cancer Treated With Bevacizumab
Recruitment status was Not yet recruiting
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.
Genetic: DNA analysis
Genetic: gene expression analysis
Genetic: polymorphism analysis
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
|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) [ Designated as safety issue: No ]
- Comparison between candidate SNP genotype and OS and HTN [ Designated as safety issue: No ]
- Comparison between VEGF amplification/deletion and median OS [ Designated as safety issue: No ]
- Comparison between VEGF amplification/deletion and VEGF expression [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Estimated Primary Completion Date:||May 2010 (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.
|Principal Investigator:||Bryan P. Schneider, MD||Indiana University Melvin and Bren Simon Cancer Center|