Studying Tumor Samples From Women Who Have Undergone Chemotherapy for Breast Cancer
NCT ID: NCT00897845
Last Updated: 2017-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2541 participants
OBSERVATIONAL
2008-06-17
2013-12-02
Brief Summary
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PURPOSE: This research study is looking at tumor samples from women who have undergone chemotherapy for breast cancer.
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Detailed Description
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Primary
* To identify gene sets for risk of recurrence using molecular profiling in samples from women with lymph node-positive or high-risk lymph node-negative breast cancer on clinical trial ECOG-E2197.
Secondary
* To define a set of significant genes as prognostic markers of recurrence.
* To compare the prognostic value of the Oncotype DX™ (ODX) 21 gene assay of clinical trial with gene sets determined in this study.
* To compare the DASL™ assay of the ODX 21 genes with ODX assay results of clinical trial.
* To compare the prognostic value of selected genes with gene sets determined in this study.
OUTLINE: This is a multicenter study.
Samples are used in molecular profiling by applying a custom panel of breast cancer-related genes to a cDNA-mediated Annealing, Selection, Extension, and Ligation (DASL™) assay, immunohistochemistry, and other studies.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Interventions
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RNA analysis
microarray analysis
immunohistochemistry staining method
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed breast cancer tumor samples collected on clinical trial ECOG-E2197
* Histologically lymph node-positive (N1-3) OR high-risk lymph node-negative disease
* Hormone receptor-positive or negative disease (status known)
* HER2 status known
PATIENT CHARACTERISTICS:
* Menopausal status not specified
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
ECOG-ACRIN Cancer Research Group
NETWORK
Responsible Party
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Principal Investigators
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Brian Leyland-Jones, MD
Role: STUDY_CHAIR
Emory University
Other Identifiers
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ECOG-E2197B-ICSC
Identifier Type: -
Identifier Source: secondary_id
E2197T2
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000598872
Identifier Type: -
Identifier Source: org_study_id
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