Biomarkers in Tissue Samples From Patients With Breast Cancer Treated With Bevacizumab
NCT ID: NCT01156168
Last Updated: 2017-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
363 participants
OBSERVATIONAL
2011-04-05
2011-09-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This research study is studying biomarkers in tissue samples from patients with breast cancer treated with bevacizumab.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Identifying Genes That Predict Recurrence in Women With Breast Cancer Treated With Chemotherapy
NCT00897299
Study of Biomarkers in Tissue Samples From Patients With Breast Cancer
NCT01004796
Identification of Genes That Predict Local Recurrence in Samples From Patients With Breast Cancer Treated on NSABP-B-28
NCT01420185
Markers for Breast Cancer
NCT00339248
Establishment of Normal Breast Epithelial Cell Lines From Patients at High Risk for Breast Cancer
NCT00001496
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
RETROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DNA analysis
gene expression analysis
polymorphism analysis
protein expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Enrolled on ECOG-E2100
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
ECOG-ACRIN Cancer Research Group
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bryan P. Schneider, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University Melvin and Bren Simon Cancer Center
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ECOG-E2100T4
Identifier Type: -
Identifier Source: secondary_id
CDR0000681004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.