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

NCT05376878 | Recruiting Phase 4 DMC FDA Drug FDA Device

• 3 other identifiers: 21050NCI-2022-03220P30CA033572
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Percent of patients with quantifiable 64Cu-DOTA-trastuzumab PET uptake

  Percentage of patient with quantifiable 64Cu-DOTA-trastuzumab PET imaging (maximum standardized uptake value\[SUVmax\]) uptake in brain lesions.

  Until disease progression or death, up to 5 years.

• Comparison of average min SUVmax values in responders versus non-responders.

  Comparison evaluated using a non-parametric test. The lowest SUVmax (minimum SUVmax) across the lesions will be the primary metric used. Response assessment for CNS disease is determined by MRI of the brain using Response Assessment in Neuro-Oncology (RANO) criteria.

  Until disease progression or death, up to 5 years.

Secondary Outcomes (1)

• Progression-free Survival

  From start of treatment until progression or death from any cause, up to 5 years.

Study Arms (1)

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

EXPERIMENTAL

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.

Other: Copper Cu 64-DOTA-Trastuzumab; Procedure: Magnetic Resonance Imaging; Device: Positron Emission Tomography; Biological: Trastuzumab; Biological: Trastuzumab Deruxtecan

Interventions

Copper Cu 64-DOTA-Trastuzumab OTHER

Given IV

Also known as: 64Cu-DOTA-Trastuzumab

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

Magnetic Resonance Imaging PROCEDURE

Undergo PET/MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

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

Positron Emission Tomography DEVICE

Undergo PET/MRI

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

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

Trastuzumab BIOLOGICAL

Given IV

Also known as: ABP 980, ALT02, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2, Anti-erbB-2, Anti-erbB2 Monoclonal Antibody, Anti-HER2/c-erbB2 Monoclonal Antibody, Anti-p185-HER2, c-erb-2 Monoclonal Antibody, HER2 Monoclonal Antibody, Herceptin, Herceptin Biosimilar PF-05280014, Herceptin Trastuzumab Biosimilar PF-05280014, Herzuma, Kanjinti, MoAb HER2, Monoclonal Antibody c-erb-2, Monoclonal Antibody HER2, Ogivri, Ontruzant, PF-05280014, rhuMAb HER2, RO0452317, SB3, Trastuzumab Biosimilar ABP 980, Trastuzumab Biosimilar ALT02, trastuzumab biosimilar EG12014, Trastuzumab Biosimilar HLX02, Trastuzumab Biosimilar PF-05280014, Trastuzumab Biosimilar SB3, Trastuzumab Biosimilar SIBP-01, Trastuzumab-anns, Trastuzumab-dkst, Trastuzumab-dttb, Trastuzumab-pkrb, Trastuzumab-qyyp, Trazimera

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

Trastuzumab Deruxtecan BIOLOGICAL

Given IV

Also known as: DS-8201, DS-8201a, Enhertu, Fam-trastuzumab Deruxtecan-nxki, WHO 10516

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Brain Neoplasms

Interventions

64Cu-DOTA-trastuzumab; Magnetic Resonance Spectroscopy; Positron-Emission Tomography; Trastuzumab; PF-05280014; Ogivri; Ontruzant; trastuzumab biosimilar HLX02; trastuzumab deruxtecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Joanne E Mortimer

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 17, 2022
• Study Start: December 21, 2022
• Primary Completion (Estimated): May 26, 2026
• Study Completion (Estimated): May 26, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

US (1)