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

Study Overview
=================
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.

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

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Genetic: RNA analysis
* Genetic: microarray analysis
* Other: immunohistochemistry staining method
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed breast cancer tumor samples collected on clinical trial ECOG-E2197 Histologically lymph node-positive (N1-3) OR high-risk lymph node-negative disease Hormone receptor-positive or negative disease (status known) HER2 status known PATIENT CHARACTERISTICS: Menopausal status not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: RNA analysis|nan|
|Genetic: microarray analysis|nan|
|Other: immunohistochemistry staining method|nan|
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of results with Outcome |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer