Breast CancerNCT00398437
Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer
A study testing trastuzumab, chemotherapy and magnetic resonance imaging in people with Breast Cancer and Metastatic Cancer, run by Jules Bordet Institute at 3 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Metastatic Cancer
- What is being tested?
- trastuzumab, chemotherapy and magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- How many people
- 96 participants
- Where
- 3 sitesBelgium
- Study dates
- Sep 2006to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites, 3 recruiting
- Recruiting
Institut Jules Bordet
Brussels, 1000
Fabienne Lebrun, MD, 32-25-413-791
- Recruiting
Centre Hospitalier Universitaire Brugmann
Brussels, B 1020
Andre Efira, MD, 32-2-477-2903, andre.efira@chu-brugmann.be
- Recruiting
Centre Hospitalier Etterbeek Ixelles
Brussels, B-1050
Jean-Pierre D. Kains, MD, 32-2-641-4851, jpkains@his.irisnet.be
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer, Metastatic Cancer
- Being tested
- trastuzumab, chemotherapy, magnetic resonance imaging
- Keywords
- tumors metastatic to brain, stage IV breast cancer
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumabBiological
chemotherapyDrug
magnetic resonance imagingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival without neurological symptoms due to brain metastasis and/or leptomeningeal involvement
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Investigators
- Fabienne Lebrun, MD, Study chair, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398437
- Sponsor's protocol ID
- IJB-HER2-NEU-CE-1384
- Other IDs
- CDR0000516004, EU-20655, EUDRACT-2006-001591
- Status last verified
- Mar 2007
- First submitted
- 9 Nov 2006
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00398437
- Acronym / sponsor ID
- IJB-HER2-NEU-CE-1384
- Conditions
- Breast Cancer, Metastatic Cancer
- Keywords
- tumors metastatic to brain, stage IV breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- Sep 2006
- First posted
- 10 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trastuzumab | Biological | – |
| chemotherapy | Drug | – |
| magnetic resonance imaging | Procedure or surgery | – |
Primary outcome
Survival without neurological symptoms due to brain metastasis and/or leptomeningeal involvement
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabienne Lebrun, MD study chair
Jules Bordet Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trastuzumab, chemotherapy and magnetic resonance imaging in people with Breast Cancer and Metastatic Cancer, run by Jules Bordet Institute at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival without neurological symptoms due to brain metastasis and/or leptomeningeal involvement. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.