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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Identifying Genomic Predictors of Recurrence After Adjuvant Chemotherapy

Conditions
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Breast Cancer, Estrogen Receptor, Her-2, Pgr

Intervention / Treatment
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* Genetic: microarray analysis
* Genetic: protein expression analysis
* Other: immunohistochemistry staining method
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: microarray analysis|nan|
|Genetic: protein expression analysis|nan|
|Other: immunohistochemistry staining method|nan|
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distant, local/regional, and ipsilateral breast relapse |  |  | 
| First breast cancer recurrence |  |  | 
| Relapse-free interval |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distant involvement at time of first recurrence |  |  | 
| Disease-free survival |  |  | 
| Overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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estrogen receptor, HER-2, PgR, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer