Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer - Full Text View

Sponsor:	Institut Jules Bordet
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00398437

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

MedlinePlus related topics: Breast Cancer Cancer MRI Scans

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

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.

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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 February 09, 2012