An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Copper Cu 64-DOTA-Trastuzumab
  • Magnetic Resonance Imaging
  • Positron Emission Tomography
  • Trastuzumab
  • Trastuzumab Deruxtecan

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator