Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer
Keywords
Abstract
Description
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.
Dates
| Last Verified: | 02/28/2007 |
| First Submitted: | 11/08/2006 |
| Estimated Enrollment Submitted: | 11/08/2006 |
| First Posted: | 11/09/2006 |
| Last Update Submitted: | 08/08/2013 |
| Last Update Posted: | 08/11/2013 |
| Actual Study Start Date: | 08/31/2006 |
Condition or disease
Intervention/treatment
Biological: trastuzumab
Drug: chemotherapy
Procedure: magnetic resonance imaging
Phase
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Survival without neurological symptoms due to brain metastasis and/or leptomeningeal involvement [undefined]
Secondary Outcome Measures
1. Total number of therapeutic procedures (i.e., gamma-knife, radiotherapy, or surgery) required for the treatment of brain metastases [undefined]
2. Total number of hospitalization days required [undefined]
3. Overall survival [undefined]
4. Cross-platform, manufacturer-independent magnetic resonance imaging technique for diagnosis of brain metastases [undefined]
5. Comparative evaluation of 2D-SE vs 3D-GE thin sections methods for post-contrast brain imaging [undefined]
