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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01156168
First Posted: July 2, 2010
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
  Purpose

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
Study Design: Observational Model: Other
Time Perspective: Retrospective
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 Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):

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

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

Enrollment: 363
Actual Study Start Date: April 5, 2011
Study Completion Date: September 8, 2011
Primary Completion Date: September 8, 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Criteria

DISEASE CHARACTERISTICS:

  • Enrolled on ECOG-E2100

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • 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)
Investigators
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
ECOG-E2100T4
First Submitted: July 1, 2010
First Posted: July 2, 2010
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
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents