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
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00398437
First received: November 9, 2006
Last updated: August 9, 2013
Last verified: March 2007

November 9, 2006
August 9, 2013
September 2006
Not Provided
Survival without neurological symptoms due to brain metastasis and/or leptomeningeal involvement [ Designated as safety issue: No ]
Survival without neurological symptoms due to brain metastasis and/or leptomeningeal involvement
Complete list of historical versions of study NCT00398437 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Total number of therapeutic procedures (i.e., gamma-knife, radiotherapy, or surgery) for brain metastases
  • Total number of hospitalization days required
  • Survival
  • Cross-platform, manufacturer-independent magnetic resonance imaging technique for diagnosis of brain metastases
  • Comparative evaluation of a 2D-SE vs 3D-GE thin sections methods for post-contrast brain imaging
Not Provided
Not Provided
 
Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer
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.

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.

Interventional
Not Provided
Allocation: Randomized
Primary Purpose: Diagnostic
  • Breast Cancer
  • Metastatic Cancer
  • Biological: trastuzumab
  • Drug: chemotherapy
  • Procedure: magnetic resonance imaging
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
96
Not Provided
Not Provided

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
Female
18 Years and older
No
Belgium
 
NCT00398437
IJB-HER2-NEU-CE-1384, CDR0000516004, EU-20655, EUDRACT-2006-001591
Not Provided
Not Provided
Institut Jules Bordet
Not Provided
Study Chair: Fabienne Lebrun, MD Institut Jules Bordet
National Cancer Institute (NCI)
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP