OBJECTIVES:
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.
