Blood Levels of Tumor Cells in Predicting Response in Patients Receiving First-Line Chemotherapy for Stage IV Breast Cancer
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|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|
|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®)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|