Imaging HER2+ Breast Cancer with Brain Metastasis using a New Scan
Pilot Study to Evaluate 64Cu-DOTA-Trastuzumab Imaging in Patients With HER2+ Breast Cancer With Brain Metastatsis Treated With Fam-Trastuzumab Deruxtecan
This study is testing a new type of scan to see if it can help doctors better understand how well a treatment works for people with HER2+ breast cancer that has spread to the brain.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | trastuzumab, chemotherapy |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT05376878 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the use of an investigational scan, 64Cu-DOTA-trastuzumab PET/MRI, to image patients with HER2+ breast cancer that has metastasized to the brain. The study aims to determine the feasibility of this imaging technique and its ability to predict responses to the standard chemotherapy treatment, trastuzumab deruxtecan. Participants will receive trastuzumab and undergo PET/MRI scans to assess the uptake of the drug in brain lesions, with follow-up MRIs every six weeks. The study will also analyze the relationship between imaging results and disease progression.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old with documented metastatic HER2 positive breast cancer and brain metastases.
Not a fit: Patients without HER2 positive breast cancer or those with significant comorbidities affecting treatment eligibility may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of imaging for HER2+ breast cancer patients with brain metastasis, leading to better treatment decisions.
How similar studies have performed: Other studies have shown promising results with similar imaging approaches, but this specific method is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Joanne E Mortimer — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.