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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00897845

Enrollment

2541

Registered

2009-05-12

Start date

2008-06-17

Completion date

2013-12-02

Last updated

2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer

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.

Interventions

GENETICRNA analysis

GENETICmicroarray analysis

OTHERimmunohistochemistry staining method

OTHERlaboratory biomarker analysis

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 120 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Correlation of results with Outcome	1 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026