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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
Information provided by (Responsible Party):

Study Description
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.

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

Detailed Description:



  • 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 Design

Study Type : Observational
Actual Enrollment : 363 participants
Observational Model: Other
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Bevacizumab
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Comparison between VEGF haplotype and median overall survival (OS) and grade 3/4 hypertension (HTN) [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Comparison between VEGF amplification/deletion and VEGF expression [ Time Frame: 1 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples from patients enrolled on E2100 from whom samples were submitted for research


  • Enrolled on ECOG-E2100


  • Not specified


  • See Disease Characteristics
Contacts and Locations

Information from the National Library of Medicine

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

Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Principal Investigator: Bryan P. Schneider, MD Indiana University Melvin and Bren Simon Cancer Center
More Information

Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT01156168     History of Changes
Other Study ID Numbers: CDR0000681004
First Posted: July 2, 2010    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
male breast cancer
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents