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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Time Perspective: Retrospective

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Bryan P. Schneider, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000472065

NCT ID:

NCT00899418

Start Date:

May 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • Breast Neoplasms

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