Blood Levels of Tumor Cells in Predicting Response in Patients Receiving First-Line Chemotherapy for Stage IV Breast Cancer
|ClinicalTrials.gov Identifier: NCT00898014|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 13, 2011
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Genetic: fluorescence in situ hybridization Other: immunologic technique Other: laboratory biomarker analysis|
- 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.
- 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|
|Estimated Enrollment :||216 participants|
|Official Title:||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|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||April 2010|
- 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®)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898014
|Institut Curie Hopital|
|Paris, France, 75248|
|Study Chair:||Jean-Yves Pierga, MD, PhD||Institut Curie|