- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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-
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Paris, France, 75248
- Institut Curie Hopital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- 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
Study Plan
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Correlation of circulating tumor cells (CTC) with overall survival
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Correlation of CTC with progression-free survival
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Secondary Outcome Measures
Outcome Measure |
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Correlation of circulating tumor cells with tumor markers, clinical response, and radiological response
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Change in HER-2 status in patients receiving trastuzumab (Herceptin®)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jean-Yves Pierga, MD, PhD, Institut Curie
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000574195
- CLCC-IC-2006-04
- INCA-RECF0474
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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