NCT Number: NCT00899418
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
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
polymerase chain reaction
Geneticpolymorphism analysis
Geneticimmunohistochemistry staining method
OtherPrimary outcomes
-
Time to progression in patients with a known polymorphism vs those with wild-type vascular endothelial growth factor (VEGF) gene
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Eastern Cooperative Oncology Group
Network
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Differential Response of Breast Cancer Patients on E2100 Treated With Bevacizumab as a Function of Genetic Polymorphisms of VEGF and KDR
Important dates
- Study start
- 2006
- Primary completion
- 2006
- First posted
- May 12, 2009
- Registry last updated
- Apr 4, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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