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

Description

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).

Conditions

Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Brain

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Study Overview

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Study Details

Study overview

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).

Pilot Study to Evaluate 64Cu-DOTA-Trastuzumab Imaging in Patients With HER2+ Breast Cancer With Brain Metastatsis Treated With Fam-Trastuzumab Deruxtecan

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

Condition
Anatomic Stage IV Breast Cancer AJCC v8
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope Medical Center, Duarte, California, United States, 91010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

City of Hope Medical Center,

Joanne E Mortimer, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

2026-02-25