Status:
RECRUITING
Monitoring Early Response to Targeted Therapy in Stage IV HER2+ Breast Cancer Patients with Advanced PET/MR Imaging
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
HER2-positive Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to see if a new group of imaging tests can help identify response to stage IV HER2+ breast cancer before treatment.
Detailed Description
The purpose of this study is to see if a new group of imaging tests can help identify response to stage IV human epidermal growth factor receptor 2 positive (HER2+) breast cancer before and during tre...
Eligibility Criteria
Inclusion
- Patients must be ≥ 18 years old and ≤ 75 years old
- 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
- Children, less than 18 years of age, will be excluded from this study
- 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)
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04273555
Start Date
March 1 2026
End Date
June 30 2028
Last Update
December 20 2024
Active Locations (1)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249