Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer
NCT ID: NCT00398437
Last Updated: 2013-08-12
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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UNKNOWN
NA
96 participants
INTERVENTIONAL
2006-09-30
Brief Summary
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PURPOSE: This randomized clinical trial is studying how well MRI finds CNS metastases in women with stage IV breast cancer.
Detailed Description
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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 resonance imaging (MRI) of the brain once every 4 months vs once every 12 months for early detection of CNS metastases.
Secondary
* Determine the total number of therapeutic procedures (i.e., gamma-knife, radiotherapy, or surgery) required for the treatment of brain metastases in these women.
* Determine the total number of hospitalization days required in these women.
* Determine the overall survival of these women.
* Evaluate a cross-platform, manufacturer-independent MRI technique for diagnosis of brain metastases that could be used in future studies in the IRIS and ULB-Canceropôle networks.
* Compare 2D-SE vs 3D-GE thin sections methods for post-contrast brain imaging in these women.
OUTLINE: This is a prospective, randomized study. Patients are randomized to 1 of 2 arms.
* Arm I: Patients undergo gadolinium-enhanced magnetic resonance imaging (MRI) of the brain at baseline (to exclude CNS involvement) and then once every 4 months (or earlier if symptoms possibly related to CNS involvement develop) in the absence of the development of CNS metastases.
* Arm II: Patients undergo gadolinium-enhanced MRI of the brain at baseline (to exclude CNS involvement) and then once every 12 months (or earlier if symptoms possibly related to CNS involvement develop) in the absence of the development of CNS metastases.
Patients complete neurological symptoms questionnaires at baseline, every 6 weeks during study intervention, and at the completion of the study.
PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
DIAGNOSTIC
Interventions
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trastuzumab
chemotherapy
magnetic resonance imaging
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Jules Bordet Institute
OTHER
Principal Investigators
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Fabienne Lebrun, MD
Role: STUDY_CHAIR
Jules Bordet Institute
Locations
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Institut Jules Bordet
Brussels, , Belgium
Centre Hospitalier Universitaire Brugmann
Brussels, , Belgium
Centre Hospitalier Etterbeek Ixelles
Brussels, , Belgium
Countries
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Facility Contacts
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Fabienne Lebrun, MD
Role: primary
Andre Efira, MD
Role: primary
Jean-Pierre D. Kains, MD
Role: primary
Other Identifiers
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CDR0000516004
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20655
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2006-001591
Identifier Type: -
Identifier Source: secondary_id
IJB-HER2-NEU-CE-1384
Identifier Type: -
Identifier Source: org_study_id