[18F]FTT Positron Emission Tomography (PET) in Patients With Metastatic Breast Cancer
University of Washington
Summary
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.
Description
OUTLINE: Patients are assigned to 1 of 2 arms. Arm I: Patients receive \[18F\]FTT intravenously (IV) and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy and again at 12 weeks. At least 1-7 days later, patients undergo SOC FDG PET/computed tomography (CT) and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening and during follow up. Arm II: Patients receive \[18F\]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy. At least 1-7 days later, patients un…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Karnofsky performance status (KPS) \>= 50% or Eastern Cooperative Oncology Group (ECOG…
Interventions
- OtherBest Practice
Receive of standard care
- ProcedureBiopsy of Breast
Undergo breast biopsy
- ProcedureComputed Tomography
Undergo FDG PET/CT
- OtherElectronic Health Record Review
Ancillary studies
- OtherFludeoxyglucose F-18
Given FDG
- RadiationFluorine F 18 Fluorthanatrace
Given IV
- DrugImmune Checkpoint Inhibitor
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington