Blood Levels of Tumor Cells in Predicting Response in Patients Receiving First-Line Chemotherapy for Stage IV Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Measuring blood levels of tumor cells in patients with breast cancer may help doctors predict how patients will respond to treatment. PURPOSE: This laboratory study is looking at blood levels of tumor cells in predicting response in patients receiving first-line chemotherapy for stage IV breast cancer.

Detailed Description
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OBJECTIVES: Primary Predict the overall and progression-free survival of patients with stage IV breast cancer by measuring the rate of circulating tumor cells (CTC) before the second course of chemotherapy. Secondary Predict overall and progression-free survival of these patients by measuring the rate of CTC before the start of chemotherapy, at the first tumor evaluation, and after 2-3 courses of chemotherapy. Correlate the detection of CTC with tumor markers, clinical response, and radiological response. Study the changing status of HER-2 in CTC in patients receiving trastuzmab (Herceptin®). OUTLINE: This is a multicenter study. Blood samples are collected at baseline, before the second course of chemotherapy, before the third or fourth course of chemotherapy, and when progressive disease is diagnosed (before second-line treatment is initiated). Circulating tumor cells from the blood samples are examined by immunofluorescence. Patients are followed periodically for up to 3 months.

Official Title
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Study Evaluating the Prognostic and Predictive Value of Response to First-Line Chemotherapy by Detection of Circulating Tumor Cells (CTC) in Patients With Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Genetic: fluorescence in situ hybridization
* Other: immunologic technique
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of stage IV breast cancer Measurable or evaluable disease Scheduled to receive first-line chemotherapy with or without trastuzumab (Herceptin®), depending on HER-2 status Histologic block available for confirming pathologic diagnosis and measuring HER-2 status via FISH PATIENT CHARACTERISTICS: Life expectancy > 3 months No other cancer in the past 5 years except for basal cell skin cancer or epithelial in situ cancer of the cervix No geographic, social, or psychiatric reasons that would make treatment impossible PRIOR CONCURRENT THERAPY: No prior chemotherapy for metastatic disease
Sexes Eligible for Study
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All

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: fluorescence in situ hybridization|nan|
|Other: immunologic technique|nan|
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of circulating tumor cells (CTC) with overall survival |  |  | 
| Correlation of CTC with progression-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of circulating tumor cells with tumor markers, clinical response, and radiological response |  |  | 
| Change in HER-2 status in patients receiving trastuzumab (Herceptin®) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer