NCT01156168

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
363

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2010

Completed
9 months until next milestone

Study Start

First participant enrolled

April 5, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2011

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

July 1, 2010

Last Update Submit

May 16, 2017

Conditions

Breast Cancer

Keywords

male breast cancerstage IV breast cancerrecurrent breast cancer

Outcome Measures

Primary Outcomes (1)

  • Comparison between VEGF haplotype and median overall survival (OS) and grade 3/4 hypertension (HTN)

    1 month

Secondary Outcomes (1)

  • Comparison between VEGF amplification/deletion and VEGF expression

    1 month

Interventions

DNA analysisGENETIC
gene expression analysisGENETIC
polymorphism analysisGENETIC
protein expression analysisGENETIC
immunohistochemistry staining methodOTHER
laboratory biomarker analysisOTHER

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Samples from patients enrolled on E2100 from whom samples were submitted for research

DISEASE CHARACTERISTICS: * Enrolled on ECOG-E2100 PATIENT CHARACTERISTICS: * 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 NeoplasmsBreast Neoplasms, Male

Interventions

Gene Expression ProfilingAmplified Fragment Length Polymorphism AnalysisImmunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesDNA FingerprintingPolymerase Chain ReactionNucleic Acid Amplification TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesImmunologic Techniques

Study Officials

  • Bryan P. Schneider, MD

    Indiana University Melvin and Bren Simon Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2010

First Posted

July 2, 2010

Study Start

April 5, 2011

Primary Completion

September 8, 2011

Study Completion

September 8, 2011

Last Updated

May 17, 2017

Record last verified: 2017-05