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Identifying Genes That Predict Recurrence in Women With Breast Cancer Treated With Chemotherapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00897299
First Posted: May 12, 2009
Last Update Posted: May 17, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Eastern Cooperative Oncology Group
May 9, 2009
May 12, 2009
May 17, 2017
October 7, 2005
October 8, 2005   (Final data collection date for primary outcome measure)
  • Distant, local/regional, and ipsilateral breast relapse
  • First breast cancer recurrence
  • Relapse-free interval
Same as current
Complete list of historical versions of study NCT00897299 on ClinicalTrials.gov Archive Site
  • Distant involvement at time of first recurrence
  • Disease-free survival
  • Overall survival
Same as current
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Identifying Genes That Predict Recurrence in Women With Breast Cancer Treated With Chemotherapy
Identifying Genomic Predictors of Recurrence After Adjuvant Chemotherapy

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. It may also help doctors predict whether cancer will come back after treatment.

PURPOSE: This laboratory study is identifying genes that may help predict recurrence in women with breast cancer treated with chemotherapy.

OBJECTIVES:

  • Assess the prognostic utility of the Oncotype DX™ 21 gene profile for risk of relapse in women with node positive or high-risk node negative breast cancer.
  • Identify individual genes whose RNA expression is associated with an increased risk of relapse in these patients.
  • Perform an exploratory analysis of individual genes whose RNA expression is associated with an increased risk of relapse differentially in patients previously treated with docetaxel.

OUTLINE: This is a multicenter study.

Tissue samples are examined for association of RNA expression and clinical factors (e.g., tumor size, nodal status, hormone receptor status, age, menopause status), as well as estrogen receptor, progesterone receptor, and HER-2/neu expression by immunohistochemistry and other studies.

PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study.

Observational
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  • Breast Cancer
  • Estrogen Receptor
  • Her-2
  • Pgr
  • Genetic: microarray analysis
  • Genetic: protein expression analysis
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
Not Provided
  • Badve SS, Baehner FL, Gray R, et al.: ER and PR assessment in ECOG 2197: comparison of locally determined IHC with centrally determined IHC and quantitative RT-PCR. [Abstract] American Society of Clinical Oncology 2007 Breast Cancer Symposium, 7-8 September 2007, San Francisco, California A-87, 2007.
  • Sparano JA, Goldstein L, Childs B, et al.: Association of individual genes with risk of relapse in operable breast cancer: analysis of E2197. [Abstract] American Society of Clinical Oncology 2007 Breast Cancer Symposium, 7-8 September 2007, San Francisco, California A-27, 2007.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
900
October 8, 2005
October 8, 2005   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer

    • Node positive OR high-risk node negative disease
    • Tumor > 1.0 cm in diameter
  • No locally advanced, inflammatory, or metastatic breast cancer
  • Previously treated with 4 courses of anthracycline-containing chemotherapy (i.e., doxorubicin and docetaxel OR doxorubicin and cyclophosphamide)
  • Enrolled on clinical trial ECOG-E2197
  • Adequate tumor material available in ECOG Pathology Coordination Center
  • Previously consented to future cancer-related research
  • Hormone receptor status known

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Sexes Eligible for Study: Female
18 Years to 120 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00897299
CDR0000456426
ECOG-E21971CSC
NCI-7613
SANOFI-AVENTIS-ECOG-E21971CSC
GENOMIC-ECOG-E21971CSC
No
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Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Joseph A. Sparano, MD Albert Einstein College of Medicine, Inc.
Investigator: Lori J. Goldstein, MD Fox Chase Cancer Center
Eastern Cooperative Oncology Group
May 2017