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

NCT00398437 | Unknown

• 4 other identifiers: IJB-HER2-NEU-CE-1384CDR0000516004EU-20655EUDRACT-2006-001591
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Cancer; Metastatic Cancer

Keywords

tumors metastatic to brain; stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• Survival without neurological symptoms due to brain metastasis and/or leptomeningeal involvement

Secondary Outcomes (5)

• 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

Interventions

trastuzumab BIOLOGICAL

chemotherapy DRUG

magnetic resonance imaging PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (3)

Institut Jules Bordet

Brussels, 1000, Belgium

RECRUITING

Centre Hospitalier Universitaire Brugmann

Brussels, B 1020, Belgium

RECRUITING

Centre Hospitalier Etterbeek Ixelles

Brussels, B-1050, Belgium

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Brain Neoplasms

Interventions

Trastuzumab; Drug Therapy; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Fabienne Lebrun, MD

  Jules Bordet Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 10, 2006
• Study Start: September 1, 2006
• Last Updated: August 12, 2013

Record last verified: 2007-03

Locations

BE (3)