Status:
RECRUITING
An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This clinical trial examines an investigational scan (64Cu-DOTA-trastuzumab positron emission tomography \[PET\]/magnetic resonance imaging \[MRI\]) in imaging patients with HER2+ breast cancer that h...
Detailed Description
PRIMARY OBJECTIVES: I. Evaluate the feasibility of 64Cu-DOTA-trastuzumab PET imaging in patients with HER2+ breast cancer metastatic to the brain. II. Evaluate if HER2+ breast cancer patients with b...
Eligibility Criteria
Inclusion
- Documented informed consent of the participant and/or legally authorized representative
- Women with documented metastatic HER2 positive breast cancer (American Society of Clinical Oncology \[ASCO\] College of American Pathologist \[CAP\] guidelines) who have brain metastases
- Age \> 18 years
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Patients with leptomeningeal disease will be considered eligible
- Planned therapy with fam-trastuzumab deruxtecan
- Left ventricular ejection fraction (LVEF) \> 50%
- Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L
- Platelets \> 100 x 10\^9/L
- Hemoglobin \> 9 g/dL
- Total (T.) bilirubin \< 3 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 x ULN
- Creatinine clearance \> 30 ml/min (by Cockcroft-Gault formula)
- Activated partial thromboplastin time (aPTT) \< 1.5 x ULN
- Prior therapy for central nervous system (CNS) disease is allowed, but at least 1 lesion \> 1.5 cm is evident on MRI
Exclusion
- Need for immediate local intervention for brain metastases
- Noninfectious interstitial lung disease or pneumonitis requiring glucocorticoids
- Clinically significant corneal disease
- Myocardial infarction \< 6 months before, congestive heart failure (CHF), unstable angina, or serious cardiac arrhythmia
Key Trial Info
Start Date :
December 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 25 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05376878
Start Date
December 21 2022
End Date
February 25 2026
Last Update
February 18 2025
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010