Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer

Jules Bordet Institute96 enrolled

Overview

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 * 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Enrollment

Conditions

Breast Cancer Metastatic Cancer

Interventions

trastuzumabBIOLOGICAL

chemotherapyDRUG

magnetic resonance imagingPROCEDURE

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Institut Jules Bordet

Brussels, Belgium

RECRUITING

Centre Hospitalier Universitaire Brugmann

Brussels, Belgium

RECRUITING

Centre Hospitalier Etterbeek Ixelles

Brussels, Belgium

RECRUITING

Outcomes

Primary Outcomes

Survival without neurological symptoms due to brain metastasis and/or leptomeningeal involvement

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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