Trial Information

Role of Gadolinium Enhanced Brain Magnetic Resonance in the Follow Up of Metastatic Breast Cancer Patients Overexpressing HER2 Neu. A Randomized Prospective Study

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.