Monitoring Early Response to Targeted Therapy in Stage IV HER2+ Breast Cancer Patients with Advanced PET/MR Imaging
NCT ID: NCT04273555
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2026-03-01
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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[18F]-Fluorodeoxyglucose (FDG) PET/ MRI
[18F]-FDG
\[18F\]-FDG will be injected prior to PET/MRI imaging up to three times over the course of six months.
Interventions
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[18F]-FDG
\[18F\]-FDG will be injected prior to PET/MRI imaging up to three times over the course of six months.
Eligibility Criteria
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Inclusion Criteria
* Patients with HER2+ metastatic breast cancer
* HER2-positive breast cancer prospectively determined on the primary tumor by a local pathology laboratory and defined as immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) (defined by ISH ratio of ≥ 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies). Only one positive result is required for eligibility
* Estrogen/progesterone receptor positive OR negative disease allowed
* Patients must have measurable disease in one metastatic lesion per RECIST v 1.1
* Stage IV HER2+ breast cancer patients eligible for a new therapeutic regimen that includes HER2-targeted treatment who are naïve to that regimen
* Estimated life expectancy of greater than six months
Exclusion Criteria
* Metastatic breast cancer patients who are HER2 positive and have already started their current HER2-targeted therapy regimen for metastatic disease
* Patients who have not recovered from grade 2 or higher toxicities of prior therapy to the point that they would be appropriate for re-dosing will be ineligible for study treatment
* Patient is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 7 months after the last dose of study treatment
* Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active infection that requires systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent).
* Patients found to have constitutionally present non-magnetic resonance (MR) compatible ferromagnetic materials
* Unable to lie still on the imaging table for one (1) hour
* Inability to receive gadolinium-based contrast agent
* Patients for whom a PET/MRI is technically not feasible (e.g. breast volume, obesity, \> body mass index (BMI) 36)
18 Years
75 Years
FEMALE
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Anna G. Sorace
Assistant Professor, Department of Radiology and Biomedical Engineering Director, The Small Animal Facility in the Advanced Medical Imaging Research Division
Principal Investigators
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Anna Sorace, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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April Riddle, BSRT
Role: primary
Anna Sorace, PhD
Role: backup
Other Identifiers
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R19-149
Identifier Type: -
Identifier Source: org_study_id