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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000516004 | Registry Identifier | PDQ (Physician Data Query) | |
| EU-20655 | |||
| EUDRACT-2006-001591 |
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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 finds CNS metastases in women with stage IV breast cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a prospective, randomized study. Patients are randomized to 1 of 2 arms.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trastuzumab | Biological | |||
| chemotherapy | Drug | |||
| magnetic resonance imaging | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Survival without neurological symptoms due to brain metastasis and/or leptomeningeal involvement |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of therapeutic procedures (i.e., gamma-knife, radiotherapy, or surgery) required for the treatment of brain metastases | ||
| Total number of hospitalization days required | ||
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DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
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
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Fabienne Lebrun, MD | Jules Bordet Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Recruiting | Brussels | 1000 | Belgium |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D004358 | Drug Therapy |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Overall survival |
| Cross-platform, manufacturer-independent magnetic resonance imaging technique for diagnosis of brain metastases |
| Comparative evaluation of 2D-SE vs 3D-GE thin sections methods for post-contrast brain imaging |
| Centre Hospitalier Universitaire Brugmann | Recruiting | Brussels | B 1020 | Belgium |
|
| Centre Hospitalier Etterbeek Ixelles | Recruiting | Brussels | B-1050 | Belgium |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |