Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Institut Jules Bordet
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00398437
First received: November 9, 2006
Last updated: August 25, 2009
Last verified: March 2007
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Metastatic Cancer |
Biological: trastuzumab Drug: chemotherapy Procedure: magnetic resonance imaging |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Diagnostic |
| Official Title: | Role of Gadolinium Enhanced Brain Magnetic Resonance in the Follow Up of Metastatic Breast Cancer Patients Overexpressing HER2 Neu. A Randomized Prospective Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Trastuzumab
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Survival without neurological symptoms due to brain metastasis and/or leptomeningeal involvement [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Total number of therapeutic procedures (i.e., gamma-knife, radiotherapy, or surgery) required for the treatment of brain metastases [ Designated as safety issue: No ]
- Total number of hospitalization days required [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Cross-platform, manufacturer-independent magnetic resonance imaging technique for diagnosis of brain metastases [ Designated as safety issue: No ]
- Comparative evaluation of 2D-SE vs 3D-GE thin sections methods for post-contrast brain imaging [ Designated as safety issue: No ]
| Estimated Enrollment: | 96 |
| Study Start Date: | September 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398437
Locations
| Belgium | |
| Centre Hospitalier Etterbeek Ixelles | Recruiting |
| Brussels, Belgium, B-1050 | |
| Contact: Jean-Pierre D. Kains, MD 32-2-641-4851 jpkains@his.irisnet.be | |
| Centre Hospitalier Universitaire Brugmann | Recruiting |
| Brussels, Belgium, B 1020 | |
| Contact: Andre Efira, MD 32-2-477-2903 andre.efira@chu-brugmann.be | |
| Institut Jules Bordet | Recruiting |
| Brussels, Belgium, 1000 | |
| Contact: Fabienne Lebrun, MD 32-25-413-791 | |
Sponsors and Collaborators
Institut Jules Bordet
Investigators
| Study Chair: | Fabienne Lebrun, MD | Institut Jules Bordet |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00398437 History of Changes |
| Other Study ID Numbers: | CDR0000516004, IJB-HER2-NEU-CE-1384, EU-20655, EUDRACT-2006-001591 |
| Study First Received: | November 9, 2006 |
| Last Updated: | August 25, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
tumors metastatic to brain stage IV breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Neoplasms by Site Breast Diseases Skin Diseases |
Neoplastic Processes Pathologic Processes Trastuzumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013