Status:
UNKNOWN
Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer
Lead Sponsor:
Jules Bordet Institute
Conditions:
Breast Cancer
Metastatic Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help doctors find CNS metastases and plan treatment. PURPOSE: This randomized clinical trial is studying how well MRI f...
Detailed Description
OBJECTIVES: Primary * Determine survival (without neurological symptoms due to CNS metastases) in women with HER2/neu-overexpressing stage IV breast cancer who undergo gadolinium-enhanced magnetic r...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Stage IV disease
- HER2/neu-overexpression (3+ by immunohistochemistry AND/OR gene amplification by fluorescence in situ hybridization)
- Undergoing treatment with trastuzumab (Herceptin®) (alone or together with chemotherapy) once weekly or 3 times weekly AND has achieved responding or stable disease for ≥ 12 weeks
- No CNS metastases (i.e., brain parenchymal lesions and/or leptomeningeal carcinomatosis)
- No uncontrolled metastatic disease at study entry
- Hormone receptor status
- Not specified
- PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- Karnofsky performance status 70-100%
- No contraindication to MRI scan
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00398437
Start Date
September 1 2006
Last Update
August 12 2013
Active Locations (3)
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1
Institut Jules Bordet
Brussels, Belgium, 1000
2
Centre Hospitalier Universitaire Brugmann
Brussels, Belgium, B 1020
3
Centre Hospitalier Etterbeek Ixelles
Brussels, Belgium, B-1050