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OpenTrials
Completed

NCT Number: NCT00897845

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–120 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RNA analysis

Genetic

microarray analysis

Genetic

immunohistochemistry staining method

Other

laboratory biomarker analysis

Other

Primary outcomes

  1. Correlation of results with Outcome

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

ECOG-ACRIN Cancer Research Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
May 12, 2009
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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