NCT05376878RecruitingPhase 4
An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis
Pilot Study to Evaluate 64Cu-DOTA-Trastuzumab Imaging in Patients With HER2+ Breast Cancer With Brain Metastatsis Treated With Fam-Trastuzumab Deruxtecan
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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 has spread to the brain (brain metastasis). Diagnostic procedures, such as 64Cu-DOTA-trastuzumab PET/MRI, may help find HER2+ breast cancer that has spread to the brain and determine whether cancer in the brain takes up trastuzumab, which may predict for response to trastuzumab deruxtecan (the standard of care chemotherapy).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 3 May 2022
- Start date
- 21 Dec 2022
- Primary completion date
- 27 Apr 2027
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05376878
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 10
- From 21 Dec 2022 to the primary completion date, 27 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Myocardial infarction \< 6 months before, congestive heart failure (CHF), unstable angina, or serious cardiac arrhythmia
Other illness
- Noninfectious interstitial lung disease or pneumonitis requiring glucocorticoids
- Clinically significant corneal disease
Other
- Need for immediate local intervention for brain metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.