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Studying Tumor Tissue Samples to Learn More About DNA Changes and Response in Patients With Breast Cancer Treated With Bevacizumab on Clinical Trial ECOG-2100

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ClinicalTrials.gov Identifier: NCT00899418
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : April 4, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Brief Summary:

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This laboratory study is examining tumor tissue samples from patients with breast cancer treated with bevacizumab on clinical trial ECOG-2100 to learn more about DNA changes and response in these patients.


Condition or disease Intervention/treatment
Breast Cancer Genetic: gene expression analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis Other: immunohistochemistry staining method

Detailed Description:

OBJECTIVES:

Primary

  • Assess the effect of known variant polymorphisms (with functionally important associations) of the vascular endothelial growth factor (VEGF) gene on outcome (time to progression) in patients with breast cancer treated with bevacizumab on clinical trial ECOG-2100.

Secondary

  • Assess the effect of known variant polymorphisms (with functionally important associations) of the VEGF receptor-2 (KDR) gene on outcome (time to progression) in these patients.
  • Assess the effect of known variant polymorphisms of these genes on efficacy (objective response rate and survival) in these patients.
  • Assess the effect of known variant polymorphisms of these genes on toxicity outcome in these patients.
  • Assess the effect of VEGF polymorphisms on VEGF expression by immunohistochemical staining (a known prognostic marker).
  • Assess the effect of KDR polymorphisms on KDR expression by immunohistochemical staining.

OUTLINE: This is a multicenter study.

Tissue and genomic DNA samples from paraffin-embedded primary tumor are examined using standard polymerase chain reaction (PCR) restriction fragment-length polymorphisms, immunohistochemistry, allele-specific PCR, and/or Taqman-based assays. Vascular endothelial growth factor (VEGF) and VEGF receptor-2 (KDR) expression and polymorphisms are assessed.

PROJECTED ACCRUAL: A total of 500 specimens will be accrued for this study.


Study Type : Observational
Estimated Enrollment : 500 participants
Time Perspective: Retrospective
Official Title: Differential Response of Breast Cancer Patients on E2100 Treated With Bevacizumab as a Function of Genetic Polymorphisms of VEGF and KDR
Study Start Date : May 2006
Primary Completion Date : November 2006

Resource links provided by the National Library of Medicine

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




Primary Outcome Measures :
  1. Time to progression in patients with a known polymorphism vs those with wild-type vascular endothelial growth factor (VEGF) gene

Secondary Outcome Measures :
  1. Time to progression in patients with a known polymorphism vs those with wild-type VEGF receptor-2 (KDR) gene
  2. Difference in response rate, survival, and toxicity in patients with a known polymorphism vs wild-type VEGF and KDR


Information from the National Library of Medicine

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the breast
  • Enrolled on clinical trial ECOG-2100 and received treatment with bevacizumab
  • Paraffin-embedded tumor samples available
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

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): NCT00899418


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

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00899418     History of Changes
Other Study ID Numbers: CDR0000472065
U10CA021115 ( U.S. NIH Grant/Contract )
ECOG-E2100T1
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: October 2008

Keywords provided by Eastern Cooperative Oncology Group:
recurrent breast cancer
stage IV 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