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Biomarkers in Tissue Samples From Patients With Breast Cancer Treated With Bevacizumab

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 1, 2010
Last updated: September 18, 2010
Last verified: June 2010

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 Intervention
Breast Cancer
Genetic: DNA analysis
Genetic: gene expression analysis
Genetic: polymorphism analysis
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: VEGF Gene Amplification/Deletion and Haplotype as Biomarkers for Bevacizumab in Breast Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Comparison between VEGF haplotype and median overall survival (OS) and grade 3/4 hypertension (HTN)
  • Comparison between candidate SNP genotype and OS and HTN
  • Comparison between VEGF amplification/deletion and median OS

Secondary Outcome Measures:
  • Comparison between VEGF amplification/deletion and VEGF expression

Estimated Enrollment: 363
Study Start Date: April 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Enrolled on ECOG-E2100


  • Not specified


  • See Disease Characteristics
  Contacts and Locations
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Please refer to this study by its identifier: NCT01156168

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Bryan P. Schneider, MD Indiana University Melvin and Bren Simon Cancer Center
  More Information

Responsible Party: Robert L. Comis, ECOG Group Chair's Office Identifier: NCT01156168     History of Changes
Other Study ID Numbers: CDR0000681004
Study First Received: July 1, 2010
Last Updated: September 18, 2010

Keywords provided by National Cancer Institute (NCI):
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 processed this record on April 28, 2017