Clinical trial · Interventional
Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer
Role of Gadolinium Enhanced Brain Magnetic Resonance in the Follow Up of Metastatic Breast Cancer Patients Overexpressing HER2 Neu. A Randomized Prospective Study
NCT00398437CI-TRIAL-00011735unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy | Drug | Chemotherapy | ALIAS |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| trastuzumab | Biological | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Survival without neurological symptoms due to brain metastasis and/or leptomeningeal involvement
Secondary outcomes (5)
- measure
- Total number of therapeutic procedures (i.e., gamma-knife, radiotherapy, or surgery) required for the treatment of brain metastases
- measure
- Total number of hospitalization days required
- measure
- Overall survival
- measure
- Cross-platform, manufacturer-independent magnetic resonance imaging technique for diagnosis of brain metastases
- measure
- Comparative evaluation of 2D-SE vs 3D-GE thin sections methods for post-contrast brain imaging
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.