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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Role of Gadolinium Enhanced Brain Magnetic Resonance in the Follow Up of Metastatic Breast Cancer Patients Overexpressing HER2 Neu. A Randomized Prospective Study

Conditions
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Breast Cancer, Metastatic Cancer

Intervention / Treatment
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* Biological: trastuzumab
* Drug: chemotherapy
* Procedure: magnetic resonance imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: trastuzumab|nan|
|Drug: chemotherapy|nan|
|Procedure: magnetic resonance imaging|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival without neurological symptoms due to brain metastasis and/or leptomeningeal involvement |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  | 
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tumors metastatic to brain, stage IV breast cancer