This clinical trial studies how well fluorine F 18 fluorthanatrace (\[18F\]FTT) positron emission tomography (PET) works in imaging patients with breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) who are receiving standard of care (SOC) poly (ADP-ribose) polymerase (PARP) inhibitors with or without immune checkpoint inhibitors (ICI) to be able to detect clinical response to PARP inhibitor ± ICI treatment. \[18F\]FTT is a radiotracer that targets and binds to PARP1 which can potentially be used for the imaging of PARP1 expression using PET. Once administered, \[18F\]FTT targets and binds to PARP1. Upon PET, PARP1-expressing tumor cells can be visualized. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case, \[18F\]FTT. Because some cancers take up \[18F\]FTT it can be seen with PET. PARP inhibitors work as a targeted therapy by blocking an enzyme involved in repairing cell damage. It may cause tumor cells to die. ICI may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Combining \[18F\]FTT with a PET scan may help detect tumor cells better in patients with metastatic breast cancer who are receiving standard of care PARP inhibitors with our without ICI treatment.
Patients must have histologically confirmed invasive breast cancer with metastatic disease
Patients must be candidates for treatment with PARP inhibitor as a single agent or for PARP inhibitor in combination with an ICI per treating physician discretion
Patients must have evaluable disease or at least one measurable lesion that can be assessed at baseline by CT (or magnetic resonance imaging [MRI]) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Age >= 18 years
Patients with prior myelodysplastic syndrome or acute myeloid leukemia due to rare risk associated with PARP inhibitor therapy
Pregnant or breastfeeding women
Patient with a known hypersensitivity to the proposed PARP inhibitor product
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Parallel
Best Practice
Other interventionReceive of standard care
Biopsy of Breast
Procedure/SurgeryUndergo breast biopsy
Computed Tomography
Procedure/SurgeryUndergo FDG PET/CT
Electronic Health Record Review
Other interventionAncillary studies
Fludeoxyglucose F-18
Other interventionGiven FDG
Fluorine F 18 Fluorthanatrace
RadiationGiven IV
Immune Checkpoint Inhibitor
DrugReceive ICI treatment
Poly (ADP-Ribose) Polymerase Inhibitor
DrugReceive PARP inhibitor treatment
Positron Emission Tomography
Procedure/SurgeryUndergo \[18F\]FTT PET
Positron Emission Tomography
Procedure/SurgeryUndergo FDG PET/CT
Overall response rate (ORR)
Will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria on poly (ADP-ribose) polymerase (PARP) inhibitor ± immune checkpoint inhibitor (ICI) treatment. Will use a boxplot to illustrate the difference of standard uptake value (SUV)max and SUVmean between responders and non-responders.
ORR
Will be assessed using RECIST 1.1 criteria on PARP inhibitor ± ICI treatment. Will use the nonparametric method Wilcoxon Rank Sum test to evaluate the difference of the changes of SUVmax and/or SUVmean between responders and non-responders.
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University of Washington
Lead sponsor
Breast Cancer Research Foundation
Collaborator
