- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00398437
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
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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 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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
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Brussels, Belgique, 1000
- Recrutement
- Institut Jules Bordet
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Contact:
- Fabienne Lebrun, MD
- Numéro de téléphone: 32-25-413-791
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Brussels, Belgique, B 1020
- Recrutement
- Centre Hospitalier Universitaire Brugmann
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Contact:
- Andre Efira, MD
- Numéro de téléphone: 32-2-477-2903
- E-mail: andre.efira@chu-brugmann.be
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Brussels, Belgique, B-1050
- Recrutement
- Centre Hospitalier Etterbeek Ixelles
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Contact:
- Jean-Pierre D. Kains, MD
- Numéro de téléphone: 32-2-641-4851
- E-mail: jpkains@his.irisnet.be
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
---|
Survival without neurological symptoms due to brain metastasis and/or leptomeningeal involvement
|
Mesures de résultats secondaires
Mesure des résultats |
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La survie globale
|
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
|
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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Fabienne Lebrun, MD, Jules Bordet Institute
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IJB-HER2-NEU-CE-1384
- CDR0000516004 (Identificateur de registre: PDQ (Physician Data Query))
- EU-20655
- EUDRACT-2006-001591
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