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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. The completion date has passed and the status has not been verified in more than two years.
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
  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:


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

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

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   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398437

Locations
Belgium
Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Contact: Fabienne Lebrun, MD    32-25-413-791      
Centre Hospitalier Universitaire Brugmann Recruiting
Brussels, Belgium, B 1020
Contact: Andre Efira, MD    32-2-477-2903    andre.efira@chu-brugmann.be   
Centre Hospitalier Etterbeek Ixelles Recruiting
Brussels, Belgium, B-1050
Contact: Jean-Pierre D. Kains, MD    32-2-641-4851    jpkains@his.irisnet.be   
Sponsors and Collaborators
Jules Bordet Institute
Investigators
Study Chair: Fabienne Lebrun, MD Jules Bordet Institute
  More Information

ClinicalTrials.gov Identifier: NCT00398437     History of Changes
Other Study ID Numbers: IJB-HER2-NEU-CE-1384
CDR0000516004 ( Registry Identifier: PDQ (Physician Data Query) )
EU-20655
EUDRACT-2006-001591
Study First Received: November 9, 2006
Last Updated: August 9, 2013

Keywords provided by National Cancer Institute (NCI):
tumors metastatic to brain
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Trastuzumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 27, 2017