Spots Global Cancer Trial Database for Studying Tumor Samples From Women Who Have Undergone Chemotherapy for Breast Cancer

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Trial Identification

Brief Title: Studying Tumor Samples From Women Who Have Undergone Chemotherapy for Breast Cancer

Official Title: Molecular Profiling of E2197 FFPE Samples Using a Custom 512 Breast Cancer Gene Set on the DASL Platform: Towards the Development of Predictive Gene Sets for Risk of Recurrence in Patients With Operable Breast Cancer Treated With Adjuvant Therapy

Study ID: NCT00897845

Conditions

Breast Cancer

Interventions

RNA analysis

microarray analysis

immunohistochemistry staining method

laboratory biomarker analysis

Study Description

Brief Summary: 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. PURPOSE: This research study is looking at tumor samples from women who have undergone chemotherapy for breast cancer.

Detailed Description: 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.