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Recruiting NCT05376878

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Copper Cu 64-DOTA-Trastuzumab, Magnetic Resonance Imaging, Positron Emission Tomography, Trastuzumab.
Who it may be relevant to
Registry conditions: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Brain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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).

Detailed description

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of 64Cu-DOTA-trastuzumab PET imaging in patients with HER2+ breast cancer metastatic to the brain.

II. Evaluate if HER2+ breast cancer patients with brain metastasis who are responders to fam-trastuzumab deruxtecan have higher maximum standardized uptake value (SUVmax) (minimum over all lesions in the brain) than non-responders.

SECONDARY OBJECTIVE:

I. Evaluate if the minimum SUVmax of all quantifiable lesions in a given patient is associated with time to progression in the brain.

OUTLINE:

Patients receive trastuzumab intravenously (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

  • Other Copper Cu 64-DOTA-Trastuzumab
    Given IV
  • Procedure Magnetic Resonance Imaging
    Undergo PET/MRI
  • Device Positron Emission Tomography
    Undergo PET/MRI
  • Biological Trastuzumab
    Given IV
  • Biological Trastuzumab Deruxtecan
    Given IV

Primary outcome measures

  • 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.]
Secondary outcome measures (1)
  • Progression-free Survival [Time frame: From start of treatment until progression or death from any cause, up to 5 years.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • City of Hope Medical Center — Duarte

Identifiers

NCT: NCT05376878 · 21050 · NCI-2022-03220 · 21050 · P30CA033572

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗