Blood Levels of Tumor Cells in Predicting Response in Patients Receiving First-Line Chemotherapy for Stage IV Breast Cancer
NCT ID: NCT00898014
Last Updated: 2011-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
216 participants
OBSERVATIONAL
2007-05-31
Brief Summary
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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.
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Detailed Description
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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
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Interventions
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fluorescence in situ hybridization
immunologic technique
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of stage IV breast cancer
* Measurable or evaluable disease
* Scheduled to receive first-line chemotherapy with or without trastuzumab (Herceptin®), depending on HER-2 status
* Histologic block available for confirming pathologic diagnosis and measuring HER-2 status via FISH
PATIENT CHARACTERISTICS:
* Life expectancy \> 3 months
* No other cancer in the past 5 years except for basal cell skin cancer or epithelial in situ cancer of the cervix
* No geographic, social, or psychiatric reasons that would make treatment impossible
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy for metastatic disease
ALL
No
Sponsors
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Institut Curie
OTHER
Principal Investigators
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Jean-Yves Pierga, MD, PhD
Role: STUDY_CHAIR
Institut Curie
Locations
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Institut Curie Hopital
Paris, , France
Countries
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Other Identifiers
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CLCC-IC-2006-04
Identifier Type: -
Identifier Source: secondary_id
INCA-RECF0474
Identifier Type: -
Identifier Source: secondary_id
CDR0000574195
Identifier Type: -
Identifier Source: org_study_id
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