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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00398437
• Other study ID #: IJB-HER2-NEU-CE-1384
• Secondary ID: CDR0000516004EU-
• Status: Recruiting
• Phase: N/A
• First received: November 9, 2006
• Last updated: August 9, 2013
• Start date: September 2006

Study information

• Verified date: March 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Biological:
• trastuzumab

Drug:
• chemotherapy

Procedure:
• magnetic resonance imaging

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Etterbeek Ixelles	Brussels
Belgium	Centre Hospitalier Universitaire Brugmann	Brussels
Belgium	Institut Jules Bordet	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Jules Bordet Institute

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival without neurological symptoms due to brain metastasis and/or leptomeningeal involvement			No
Secondary	Total number of therapeutic procedures (i.e., gamma-knife, radiotherapy, or surgery) required for the treatment of brain metastases			No
Secondary	Total number of hospitalization days required			No
Secondary	Overall survival			No
Secondary	Cross-platform, manufacturer-independent magnetic resonance imaging technique for diagnosis of brain metastases			No
Secondary	Comparative evaluation of 2D-SE vs 3D-GE thin sections methods for post-contrast brain imaging			No