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

Last updated: February 17, 2025
Sponsor: City of Hope Medical Center
Overall Status: Active - Recruiting

Phase

4

Condition

Neoplasms

Treatment

Trastuzumab Deruxtecan

Copper Cu 64-DOTA-Trastuzumab

Trastuzumab

Clinical Study ID

NCT05376878
21050
21050
P30CA033572
NCI-2022-03220
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented informed consent of the participant and/or legally authorizedrepresentative

  • Women with documented metastatic HER2 positive breast cancer (American Society ofClinical Oncology [ASCO] College of American Pathologist [CAP] guidelines) who havebrain 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 1lesion > 1.5 cm is evident on MRI

Exclusion

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), unstableangina, or serious cardiac arrhythmia

Study Design

Total Participants: 10
Treatment Group(s): 5
Primary Treatment: Trastuzumab Deruxtecan
Phase: 4
Study Start date:
December 21, 2022
Estimated Completion Date:
February 25, 2026

Study 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.

Connect with a study center

  • City of Hope Medical Center

    Duarte, California 91010
    United States

    Active - Recruiting

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