Trial Information

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.