Imaging HER2+ Breast Cancer with Brain Metastasis using a New Scan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting

Study contacts

• Principal investigator: Joanne E Mortimer — City of Hope Medical Center

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.