This phase I/II 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.
Additional locations may be listed on ClinicalTrials.gov for NCT06502691.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Active
Contact: Jennifer Marie Specht
Phone: 206-606-6889
PRIMARY OBJECTIVE:
I. Determine whether pre-treatment [18F]FTT tumor uptake predicts for clinical response to poly (ADP-ribose) polymerase (PARP) inhibitor ± immune checkpoint inhibitor (ICI) treatment in metastatic breast cancer.
SECONDARY OBJECTIVE:
I. Determine whether change in [18F]FTT tumor uptake on treatment when compared to baseline (pre-treatment) predicts for clinical response to PARP inhibitor ± ICI treatment in metastatic breast cancer.
EXPLORATORY OBJECTIVES:
I. Evaluate the association between presence of immune markers in metastatic tissue biopsy prior to PARP inhibitor ± ICI treatment with overall response rate at 6 months.
II. Evaluate the association between presence of immune markers in metastatic tissue biopsy and [18F]FTT PET uptake with overall response rate at 6 months.
III. Assess FTT-positive tumor volume-based changes (obtained pre-treatment and 12 ± 4 weeks) as a predictor of response, defined by thresholding all tumor sites with [18F]FTT uptake above background.
IV. Assess relationship of pre-treatment [18F]FTT PET tumor uptake and change in tumor volume with fludeoxyglucose F-18 (FDG) PET modified PET Response Criteria in Solid Tumors (PERCIST) assessment of response at baseline and 12-week scans.
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 undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening.
After initial [18F]FTT PET imaging, patients are followed-up to 6 months or until disease progression.
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorJennifer Marie Specht
