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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01156168
First received: July 1, 2010
Last updated: September 18, 2010
Last verified: June 2010
History of Changes
  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
Official Title: VEGF Gene Amplification/Deletion and Haplotype as Biomarkers for Bevacizumab in Breast Cancer

Resource links provided by NLM:

Drug Information available for: Bevacizumab
U.S. FDA Resources

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) [ Designated as safety issue: No ]
  • Comparison between candidate SNP genotype and OS and HTN [ Designated as safety issue: No ]
  • Comparison between VEGF amplification/deletion and median OS [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison between VEGF amplification/deletion and VEGF expression [ Designated as safety issue: No ]

Estimated Enrollment: 363
Study Start Date: April 2010
Estimated Primary Completion Date: May 2010 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Enrolled on ECOG-E2100

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

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

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT01156168     History of Changes
Other Study ID Numbers: CDR0000681004, ECOG-E2100T4
Study First Received: July 1, 2010
Last Updated: September 18, 2010
Health Authority: Unspecified

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
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013