Biomarkers in Tissue Samples From Patients With Breast Cancer Treated With Bevacizumab
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|ClinicalTrials.gov Identifier: NCT01156168|
Recruitment Status : Completed
First Posted : July 2, 2010
Last Update Posted : May 17, 2017
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Genetic: DNA analysis Genetic: gene expression analysis Genetic: polymorphism analysis Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||363 participants|
|Official Title:||VEGF Gene Amplification/Deletion and Haplotype as Biomarkers for Bevacizumab in Breast Cancer|
|Actual Study Start Date :||April 5, 2011|
|Primary Completion Date :||September 8, 2011|
|Study Completion Date :||September 8, 2011|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156168
|Principal Investigator:||Bryan P. Schneider, MD||Indiana University Melvin and Bren Simon Cancer Center|