Studying Tissue Samples From Women Who Underwent Chemotherapy for Lymph Node-Positive Stage II or Stage IIIA Breast Cancer on Clinical Trial CLB-9741 or CLB-9344

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 plan the best treatment. PURPOSE: This research study is looking at tissue samples from women who underwent chemotherapy for lymph node-positive stage II or stage IIIA breast cancer.

Detailed Description
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OBJECTIVES: Primary To identify biomarkers that can be used to individually tailor the use of adjuvant dose-dense therapy in women with stage II or IIIA breast cancer. Secondary To identify groups of patients who have a poor prognosis despite adjuvant chemotherapy and who should be prospectively targeted for new approaches to adjuvant treatment. OUTLINE: This is a multicenter study. Tissue samples are collected from patients. Tissue samples are analyzed by immunohistochemistry (Ki67, CK5/6, EGFR, ER) and fluorescence in situ hybridization (FISH).

Official Title
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ER/HER2/Ki67 Breast Cancer Subtypes as Predictive Factors for Response to Adjuvant Dose-dense Therapy, and Basal Subtypes of Double-negative Breast Cancer as Prognostic Factors in Intergroup Trial C9741

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: cyclophosphamide
* Drug: doxorubicin hydrochloride
* Drug: paclitaxel
* Genetic: fluorescence in situ hybridization
* Other: immunohistochemistry staining method


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of node-positive breast cancer Stage II-IIIA disease Underwent adjuvant chemotherapy on trial CLB-9741 or CLB-9344 Hormone receptor status not specified

Ages Eligible for Study
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Minimum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Tissue samples are collected from patients. Tissue samples are analyzed by immunohistochemistry (Ki67, CK5/6, EGFR, ER) and fluorescence in situ hybridization (FISH). | Drug: cyclophosphamide<br> <br> Drug: doxorubicin hydrochloride<br> <br> Drug: paclitaxel<br> <br> Genetic: fluorescence in situ hybridization<br> <br> Other: immunohistochemistry staining method<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II breast cancer, stage IIIA breast cancer