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
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.
Observational
N/A
Correlation of circulating tumor cells (CTC) with overall survival
No
Jean-Yves Pierga, MD, PhD
Study Chair
Institut Curie
United States: Federal Government
CDR0000574195
NCT00898014
May 2007
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