NCT05376878 An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis
| NCT ID | NCT05376878 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | City of Hope Medical Center |
| Condition | Anatomic Stage IV Breast Cancer AJCC v8 |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2022-12-21 |
| Primary Completion | 2026-05-26 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 10 participants in total. It began in 2022-12-21 with a primary completion date of 2026-05-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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).
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Joanne E Mortimer
PRINCIPAL INVESTIGATOR
City of Hope Medical Center
Frequently Asked Questions
Who can join the NCT05376878 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anatomic Stage IV Breast Cancer AJCC v8. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05376878 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05376878 currently recruiting?
Yes, NCT05376878 is actively recruiting participants. Visit ClinicalTrials.gov or contact City of Hope Medical Center to inquire about joining.
Where is the NCT05376878 trial being conducted?
This trial is being conducted at Duarte, United States.
Who is sponsoring the NCT05376878 clinical trial?
NCT05376878 is sponsored by City of Hope Medical Center. The principal investigator is Joanne E Mortimer at City of Hope Medical Center. The trial plans to enroll 10 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.