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

Primary Purpose

Breast Cancer, Estrogen Receptor, Her-2

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
microarray analysis
protein expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Breast Cancer focused on measuring estrogen receptor, HER-2, PgR, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    May 9, 2009
    Last Updated
    May 16, 2017
    Sponsor
    Eastern Cooperative Oncology Group
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00897299
    Brief Title
    Identifying Genes That Predict Recurrence in Women With Breast Cancer Treated With Chemotherapy
    Official Title
    Identifying Genomic Predictors of Recurrence After Adjuvant Chemotherapy
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 7, 2005 (Actual)
    Primary Completion Date
    October 8, 2005 (Actual)
    Study Completion Date
    October 8, 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Eastern Cooperative Oncology Group
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Estrogen Receptor, Her-2, Pgr
    Keywords
    estrogen receptor, HER-2, PgR, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer

    7. Study Design

    Enrollment
    900 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Genetic
    Intervention Name(s)
    microarray analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    protein expression analysis
    Intervention Type
    Other
    Intervention Name(s)
    immunohistochemistry staining method
    Intervention Type
    Other
    Intervention Name(s)
    laboratory biomarker analysis
    Primary Outcome Measure Information:
    Title
    Distant, local/regional, and ipsilateral breast relapse
    Title
    First breast cancer recurrence
    Title
    Relapse-free interval
    Secondary Outcome Measure Information:
    Title
    Distant involvement at time of first recurrence
    Title
    Disease-free survival
    Title
    Overall survival

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joseph A. Sparano, MD
    Organizational Affiliation
    Albert Einstein College of Medicine
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Lori J. Goldstein, MD
    Organizational Affiliation
    Fox Chase Cancer Center

    12. IPD Sharing Statement

    Citations:
    Citation
    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.
    Results Reference
    result
    Citation
    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.
    Results Reference
    result

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

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