Monitoring Early Response to Targeted Therapy in Stage IV HER2+ Breast Cancer Patients With Advanced PET/MR Imaging
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
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 treatment. This study will test a new method for monitoring treatment. The investigators will use [18F]-Fluorodeoxyglucose (FDG) positron emission tomography (PET)/magnetic resonance imaging (MRI) to look at previously diagnosed stage IV breast cancer and image up to three times during therapy. FDG is a non-natural amino acid with a radioactive tag that is used clinically for staging of disease. However, the role of FDG-PET/MRI for imaging response in breast cancer is not currently clear. PET/MRI is a new imaging technique that combines PET and MRI into a single study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: [18F]-Fluorodeoxyglucose (FDG) PET/ MRI
|
Drug: [18F]-FDG
[18F]-FDG will be injected prior to PET/MRI imaging up to three times over the course of six months.
|
Outcome Measures
Primary Outcome Measures
- Baseline measure of PET standardized uptake value (SUV). [Baseline imaging visit 1]
Compare baseline metrics from PET/MRI
- Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI. [Baseline imaging visit 1]
Compare baseline metrics from PET/MRI
- Baseline measure of signal enhancement ratio (SER) from MRI. [Baseline imaging visit 1]
Compare baseline metrics from PET/MRI
- Changes in SER from MRI [Baseline through 6 months]
Compare percent change of SER from imaging visit 3 to the baseline.
- Changes in ADC from MRI [Baseline through 6 months]
Compare percent change of ADC (mm2/sec) from imaging visit 3 to the baseline.
- Changes in SUV from PET [Baseline through 6 months]
Compare percent change of SUV from imaging visit 3 to the baseline.
Secondary Outcome Measures
- Follow-up [Baseline through 5 year follow-up]
Compare changes in imaging metrics to disease progression (defined as clinical progression of disease through increase in lesion size or increase in number of lesions).
- Changes in ADC (mm2/sec) from MRI. [Baseline through 2 months]
Compare percent change from imaging visit 2 to the baseline.
- Changes in SER from MRI. [Baseline through 2 months]
Compare percent change from imaging visit 2 to the baseline.
- Changes in SUV from PET. [Baseline through 2 months]
Compare percent change from imaging visit 2 to the baseline.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients must be ≥ 18 years old and ≤ 75 years old
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Patients with HER2+ metastatic breast cancer
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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
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Estrogen/progesterone receptor positive OR negative disease allowed
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Patients must have measurable disease in one metastatic lesion per RECIST v 1.1
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Stage IV HER2+ breast cancer patients eligible for a new therapeutic regimen that includes HER2-targeted treatment who are naïve to that regimen
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Estimated life expectancy of greater than six months
Exclusion Criteria:
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Children, less than 18 years of age, will be excluded from this study
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Metastatic breast cancer patients who are HER2 positive and have already started their current HER2-targeted therapy regimen for metastatic disease
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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
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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
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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).
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Patients found to have constitutionally present non-magnetic resonance (MR) compatible ferromagnetic materials
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Unable to lie still on the imaging table for one (1) hour
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Inability to receive gadolinium-based contrast agent
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Patients for whom a PET/MRI is technically not feasible (e.g. breast volume, obesity,
body mass index (BMI) 36)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Alabama at Birmingham | Birmingham | Alabama | United States | 35249 |
Sponsors and Collaborators
- University of Alabama at Birmingham
Investigators
- Principal Investigator: Anna Sorace, PhD, University of Alabama at Birmingham
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R19-149