Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer
Primary Purpose
Breast Cancer, Metastatic Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
trastuzumab
chemotherapy
magnetic resonance imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring tumors metastatic to brain, stage IV breast cancer
Eligibility 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
Sites / Locations
- Institut Jules BordetRecruiting
- Centre Hospitalier Universitaire BrugmannRecruiting
- Centre Hospitalier Etterbeek IxellesRecruiting
Outcomes
Primary Outcome Measures
Survival without neurological symptoms due to brain metastasis and/or leptomeningeal involvement
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00398437
First Posted
November 9, 2006
Last Updated
August 9, 2013
Sponsor
Jules Bordet Institute
1. Study Identification
Unique Protocol Identification Number
NCT00398437
Brief Title
Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Jules Bordet Institute
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Metastatic Cancer
Keywords
tumors metastatic to brain, stage IV breast cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
trastuzumab
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Primary Outcome Measure Information:
Title
Survival without neurological symptoms due to brain metastasis and/or leptomeningeal involvement
Secondary Outcome Measure Information:
Title
Total number of therapeutic procedures (i.e., gamma-knife, radiotherapy, or surgery) required for the treatment of brain metastases
Title
Total number of hospitalization days required
Title
Overall survival
Title
Cross-platform, manufacturer-independent magnetic resonance imaging technique for diagnosis of brain metastases
Title
Comparative evaluation of 2D-SE vs 3D-GE thin sections methods for post-contrast brain imaging
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabienne Lebrun, MD
Organizational Affiliation
Jules Bordet Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabienne Lebrun, MD
Phone
32-25-413-791
Facility Name
Centre Hospitalier Universitaire Brugmann
City
Brussels
ZIP/Postal Code
B 1020
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Efira, MD
Phone
32-2-477-2903
Email
andre.efira@chu-brugmann.be
Facility Name
Centre Hospitalier Etterbeek Ixelles
City
Brussels
ZIP/Postal Code
B-1050
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre D. Kains, MD
Phone
32-2-641-4851
Email
jpkains@his.irisnet.be
12. IPD Sharing Statement
Learn more about this trial
Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer
We'll reach out to this number within 24 hrs