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

ConditionsAnatomic Stage IV Breast Cancer AJCC v8Metastatic Breast CarcinomaMetastatic Malignant Neoplasm in the Brain
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Copper Cu 64-DOTA-Trastuzumab

    Other intervention

    Given IV

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo PET/MRI

  • Positron Emission Tomography

    Device

    Undergo PET/MRI

  • Trastuzumab

    Biological/Vaccine

    Given IV

  • Trastuzumab Deruxtecan

    Biological/Vaccine

    Given IV

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Treatment ( 64Cu-DOTA-trastuzumab PET/MRI)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Until disease progression or death, up to 5 years.
2

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.

Time frame
Until disease progression or death, up to 5 years.

Secondary outcomes

1

Progression-free Survival

Estimated using the product-limit method of Kaplan and Meier. Progression defined by any of the following: \> 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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