NCT Number: NCT01156168
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.
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Notify MeKey information
Conditions
Age range
18 year–120 year
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
- Enrolled on ECOG-E2100
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Treatment and study plan
gene expression analysis
Geneticpolymorphism analysis
Geneticprotein expression analysis
Geneticimmunohistochemistry staining method
Otherlaboratory biomarker analysis
OtherPrimary outcomes
-
Comparison between VEGF haplotype and median overall survival (OS) and grade 3/4 hypertension (HTN)
Time frame: 1 month
Secondary outcomes
-
Comparison between VEGF amplification/deletion and VEGF expression
Time frame: 1 month
Sponsors and collaborators
Lead sponsor
ECOG-ACRIN Cancer Research Group
Network
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
VEGF Gene Amplification/Deletion and Haplotype as Biomarkers for Bevacizumab in Breast Cancer
Important dates
- Study start
- 2011
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Jul 2, 2010
- Registry last updated
- May 17, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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