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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01156168
Enrollment
363
Registered
2010-07-02
Start date
2011-04-05
Completion date
2011-09-08
Last updated
2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

male breast cancer, stage IV breast cancer, recurrent breast cancer

Brief 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.

Interventions

GENETICDNA analysis
GENETICgene expression analysis
GENETICpolymorphism analysis
GENETICprotein expression analysis
OTHERimmunohistochemistry staining method
OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
ECOG-ACRIN Cancer Research Group
Lead SponsorNETWORK

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Enrolled on ECOG-E2100 PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Design outcomes

Primary

MeasureTime frame
Comparison between VEGF haplotype and median overall survival (OS) and grade 3/4 hypertension (HTN)1 month

Secondary

MeasureTime frame
Comparison between VEGF amplification/deletion and VEGF expression1 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026