Status:

COMPLETED

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

Lead Sponsor:

Eastern Cooperative Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Estrogen Receptor

Eligibility:

FEMALE

18-120 years

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 al...

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 w...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 7 2005

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    October 8 2005

    Estimated Enrollment :

    900 Patients enrolled

    Trial Details

    Trial ID

    NCT00897299

    Start Date

    October 7 2005

    End Date

    October 8 2005

    Last Update

    May 17 2017

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