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

Breast Cancer Clinical Trial

Official title:

Differential Response of Breast Cancer Patients on E2100 Treated With Bevacizumab as a Function of Genetic Polymorphisms of VEGF and KDR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00899418
• Other study ID #: CDR0000472065
• Secondary ID: U10CA021115ECOG-
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: April 2, 2013
• Start date: May 2006

Study information

• Verified date: October 2008
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• gene expression analysis

• polymerase chain reaction

• polymorphism analysis

Other:
• immunohistochemistry staining method

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression in patients with a known polymorphism vs those with wild-type vascular endothelial growth factor (VEGF) gene			No
Secondary	Time to progression in patients with a known polymorphism vs those with wild-type VEGF receptor-2 (KDR) gene			No
Secondary	Difference in response rate, survival, and toxicity in patients with a known polymorphism vs wild-type VEGF and KDR			No