Studying Tumor Tissue Samples to Learn More About DNA Cha... | NCT00899418

Studies
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

NCT00899418

Sponsor

Eastern Cooperative Oncology Group

Status

Completed

Last Update Posted

Apr 4, 2013Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

gene expression analysis
polymerase chain reaction
polymorphism analysis
immunohistochemistry staining method

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
U10CA021115	U.S. NIH Grant/Contract		View source
ECOG-E2100T1

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Nov 2006Actual

Completion Date

Not provided

First Submitted Date

May 9, 2009

First Submission Date that Met QC Criteria

May 9, 2009

First Posted Date

May 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2013

Last Update Posted Date

Apr 4, 2013Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gene expression analysis	Genetic
polymerase chain reaction	Genetic
polymorphism analysis	Genetic
immunohistochemistry staining method	Other

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bryan P. Schneider, MD	Indiana University	Study Chair

Locations

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D020869	Gene Expression Profiling
D016133	Polymerase Chain Reaction
D054458	Amplified Fragment Length Polymorphism Analysis
D007150	Immunohistochemistry

Ancestor Terms

ID	Term
D005821	Genetic Techniques
D008919	Investigative Techniques
D021141	Nucleic Acid Amplification Techniques
D016172	DNA Fingerprinting
D006651	Histocytochemistry
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D006652	Histological Techniques
D007158	Immunologic Techniques