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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT05376878
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Copper Cu 64-DOTA-Trastuzumab — OTHER
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo PET/MRI
  • Positron Emission Tomography — DEVICE
    Undergo PET/MRI
  • Trastuzumab — BIOLOGICAL
    Given IV
  • Trastuzumab Deruxtecan — BIOLOGICAL
    Given IV

Study Details

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).

Key Dates

Start date
Dec 21, 2022
Status verified
Feb 2026
Primary completion
May 26, 2026
Completion
May 26, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

Percent of patients with quantifiable 64Cu-DOTA-trastuzumab PET uptake [ Time Frame: Until disease progression or death, up to 5 years. ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Joanne E. Mortimer
[email protected]
626-256-4673
Joanne E. Mortimer (PRINCIPAL_INVESTIGATOR)

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City of Hope Medical Center· Duarte, CA

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