Breast Cancer Clinical Trial
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
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.
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.
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