Studying Tumor Samples From Women Who Have Undergone Chemotherapy for Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00897845
- Lead Sponsor
- ECOG-ACRIN Cancer Research Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2541
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation of results with Outcome 1 month
- Secondary Outcome Measures
Name Time Method