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

Primary Purpose

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

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Copper Cu 64-DOTA-Trastuzumab
Magnetic Resonance Imaging
Positron Emission Tomography
Trastuzumab
Trastuzumab Deruxtecan
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anatomic Stage IV Breast Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 3, 2022
Last Updated
February 14, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05376878
Brief Title
An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis
Official Title
Pilot Study to Evaluate 64Cu-DOTA-Trastuzumab Imaging in Patients With HER2+ Breast Cancer With Brain Metastatsis Treated With Fam-Trastuzumab Deruxtecan
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2022 (Actual)
Primary Completion Date
February 25, 2025 (Anticipated)
Study Completion Date
February 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Brain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment ( 64Cu-DOTA-trastuzumab PET/MRI)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Copper Cu 64-DOTA-Trastuzumab
Other Intervention Name(s)
64Cu-DOTA-Trastuzumab
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo PET/MRI
Intervention Type
Device
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo PET/MRI
Intervention Type
Biological
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
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
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Trastuzumab Deruxtecan
Other Intervention Name(s)
DS-8201, DS-8201a, Enhertu, Fam-trastuzumab Deruxtecan-nxki, WHO 10516
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Percent of patients with quantifiable 64Cu-DOTA-trastuzumab PET uptake
Description
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.
Title
Comparison of average min SUVmax values in responders versus non-responders.
Description
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 Outcome Measure Information:
Title
Progression-free Survival
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne E Mortimer
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanne E. Mortimer
Phone
626-256-4673
Ext
81218
Email
jmortimer@coh.org
First Name & Middle Initial & Last Name & Degree
Joanne E. Mortimer

12. IPD Sharing Statement

Learn more about this trial

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

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