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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
  Purpose

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.


Condition Intervention
Breast Cancer Estrogen Receptor Her-2 Pgr Genetic: microarray analysis Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Identifying Genomic Predictors of Recurrence After Adjuvant Chemotherapy

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Distant, local/regional, and ipsilateral breast relapse
  • First breast cancer recurrence
  • Relapse-free interval

Secondary Outcome Measures:
  • Distant involvement at time of first recurrence
  • Disease-free survival
  • Overall survival

Estimated Enrollment: 900
Actual Study Start Date: October 7, 2005
Study Completion Date: October 8, 2005
Primary Completion Date: October 8, 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00897299


Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Joseph A. Sparano, MD Albert Einstein College of Medicine, Inc.
OverallOfficial: Lori J. Goldstein, MD Fox Chase Cancer Center
  More Information

Publications:
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.

ClinicalTrials.gov Identifier: NCT00897299     History of Changes
Other Study ID Numbers: CDR0000456426
ECOG-E21971CSC
NCI-7613
SANOFI-AVENTIS-ECOG-E21971CSC
GENOMIC-ECOG-E21971CSC
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Eastern Cooperative Oncology Group:
estrogen receptor
HER-2
PgR
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Recurrence
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes