Recruiting

64Cu-DOTA-Trastuzumab

Sponsor:

City of Hope Medical Center

Code:

NCT05376878

Conditions

Anatomic Stage IV Breast Cancer AJCC v8

Metastatic Breast Carcinoma

Metastatic Malignant Neoplasm in the Brain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Copper Cu 64-DOTA-Trastuzumab

Magnetic Resonance Imaging

Positron Emission Tomography

Trastuzumab

Trastuzumab Deruxtecan

Study Details

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).

Conditions

Anatomic Stage IV Breast Cancer AJCC v8

Metastatic Breast Carcinoma

Metastatic Malignant Neoplasm in the Brain

Study ID

NCT05376878

Start date

Dec 21, 2022

Status verified date

Jun, 2026

Completion date

Apr 27, 2027

Anticipated

Primary completion date

Apr 27, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Treatment ( 64Cu-DOTA-trastuzumab PET/MRI)

Patients receive trastuzumab IV over 15 minutes on day 0. Patients then receive 64Cu-DOTA-trastuzumab IV and then undergo PET/MRI scan on day 1. Patients undergo repeat brain MRI every 6 weeks for 24 weeks and then every 9 weeks until disease progression. Patients then receive trastuzumab deruxtecan IV every 21 days in the absence of disease progression or unacceptable toxicity.

Interventions

Copper Cu 64-DOTA-Trastuzumab

Given IV

Magnetic Resonance Imaging

Undergo PET/MRI

Positron Emission Tomography

Undergo PET/MRI

Trastuzumab

Given IV

Trastuzumab Deruxtecan

Given IV

Primary outcome measure

  • Percent of patients with quantifiable 64Cu-DOTA-trastuzumab PET uptake [ Time Frame: Until disease progression or death, up to 5 years. ]
  • Comparison of average min SUVmax values in responders versus non-responders. [ Time Frame: Until disease progression or death, up to 5 years. ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Joanne E. Mortimer

626-256-4673jmortimer@coh.org

Principal Investigator:

Joanne E. Mortimer

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-07-01.