Studying Tumor Samples From Women Who Have Undergone Chemotherapy for Breast Cancer
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.
|Breast Cancer||Genetic: RNA analysis Genetic: microarray analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis|
|Study Design:||Observational Model: Other
Time Perspective: Retrospective
|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|
- Correlation of results with Outcome [ Time Frame: 1 month ]
|Actual Study Start Date:||June 17, 2008|
|Study Completion Date:||December 2, 2013|
|Primary Completion Date:||December 2, 2013 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897845
|Study Chair:||Brian Leyland-Jones, MD||Emory University|