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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00897845
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 17, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( 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.

Condition or disease Intervention/treatment
Breast Cancer Genetic: RNA analysis Genetic: microarray analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis

Detailed Description:



  • 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.


  • 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.

Study Type : Observational
Actual Enrollment : 2541 participants
Observational Model: Other
Time Perspective: Retrospective
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
Actual Study Start Date : June 17, 2008
Actual Primary Completion Date : December 2, 2013
Actual Study Completion Date : December 2, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Correlation of results with Outcome [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples submitted for research from patients enrolled on E2197


  • 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


  • Menopausal status not specified


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00897845

Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Study Chair: Brian Leyland-Jones, MD Emory University

Responsible Party: ECOG-ACRIN Cancer Research Group Identifier: NCT00897845     History of Changes
Other Study ID Numbers: CDR0000598872
E2197T2 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases