NCT00898014

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 216 (estimated)
• Sponsor: Institut Curie · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
GENETIC	fluorescence in situ hybridization
OTHER	immunologic technique
OTHER	laboratory biomarker analysis

Timeline

• Start date: 2007-05-01
• Primary completion: 2010-04-01
• First posted: 2009-05-12
• Last updated: 2011-05-13

Locations

1 site across 1 country: France