Biomarkers in Tissue Samples From Patients With Breast Cancer Treated With Bevacizumab
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
male breast cancer, stage IV breast cancer, recurrent breast cancer
Study Type
Observational
Study Phase
N/A
Study Design
N/A
Intervention
Name: DNA analysis Type: Genetic
Name: gene expression analysis Type: Genetic
Name: polymorphism analysis Type: Genetic
Name: protein expression analysis Type: Genetic
Name: immunohistochemistry staining method Type: Other
Name: laboratory biomarker analysis Type: Other
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: DISEASE CHARACTERISTICS:

- Enrolled on ECOG-E2100

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics
Location
Start Date
April 2010
Sponsors
Eastern Cooperative Oncology Group
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page