NCT00398437Unknown不适用
Role of Gadolinium Enhanced Brain Magnetic Resonance in the Follow Up of Metastatic Breast Cancer Patients Overexpressing HER2 Neu. A Randomized Prospective Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 96
- 试验地点
- 3
- 主要终点
- Survival without neurological symptoms due to brain metastasis and/or leptomeningeal involvement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Diagnostic
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •Menopausal status not specified
- •Karnofsky performance status 70-100%
- •No contraindication to MRI scan
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Survival without neurological symptoms due to brain metastasis and/or leptomeningeal involvement
次要结局
- 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
研究者
研究点 (3)
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