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

ECOG-ACRIN Cancer Research Group

Status: Completed

Conditions: Breast Cancer

Treatments: Genetic: RNA analysis; Genetic: microarray analysis; Other: laboratory biomarker analysis; Other: immunohistochemistry staining method

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00897845

E2197T2 (Other Identifier)

ECOG-E2197B-ICSC

CDR0000598872

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,541 patients

Sex: Female

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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