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.
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.
Study Type
OBSERVATIONAL
Enrollment
216
Institut Curie Hopital
Paris, France
Correlation of circulating tumor cells (CTC) with overall survival
Correlation of CTC with progression-free survival
Correlation of circulating tumor cells with tumor markers, clinical response, and radiological response
Change in HER-2 status in patients receiving trastuzumab (Herceptin®)
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