Studying Tumor Samples From Women Who Have Undergone Chemotherapy for Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
Study Type
Observational
Study Phase
N/A
Study Design
N/A
Intervention
Name: RNA analysis Type: Genetic
Name: microarray analysis Type: Genetic
Name: immunohistochemistry staining method Type: Other
Name: laboratory biomarker analysis Type: Other
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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
Location
Start Date
January 2009
Sponsors
Eastern Cooperative Oncology Group
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page