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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

E

Eastern Cooperative Oncology Group

Status

Completed

Conditions

Breast Cancer

Treatments

Genetic: gene expression analysis
Other: immunohistochemistry staining method
Genetic: polymerase chain reaction
Genetic: polymorphism analysis

Study type

Observational

Funder types

NETWORK
NIH

Identifiers

NCT00899418
CDR0000472065
ECOG-E2100T1
U10CA021115 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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