NCT00899418

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

April 4, 2013

Status Verified

October 1, 2008

Enrollment Period

6 months

First QC Date

May 9, 2009

Last Update Submit

April 2, 2013

Conditions

Breast Cancer

Keywords

recurrent breast cancerstage IV breast cancer

Outcome Measures

Primary Outcomes (1)

  • Time to progression in patients with a known polymorphism vs those with wild-type vascular endothelial growth factor (VEGF) gene

Secondary Outcomes (2)

  • Time to progression in patients with a known polymorphism vs those with wild-type VEGF receptor-2 (KDR) gene

  • Difference in response rate, survival, and toxicity in patients with a known polymorphism vs wild-type VEGF and KDR

Interventions

gene expression analysisGENETIC
polymerase chain reactionGENETIC
polymorphism analysisGENETIC
immunohistochemistry staining methodOTHER

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gene Expression ProfilingPolymerase Chain ReactionAmplified Fragment Length Polymorphism AnalysisImmunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesNucleic Acid Amplification TechniquesDNA FingerprintingHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesImmunologic Techniques

Study Officials

  • Bryan P. Schneider, MD

    Indiana University Melvin and Bren Simon Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

May 1, 2006

Primary Completion

November 1, 2006

Last Updated

April 4, 2013

Record last verified: 2008-10