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[18F]FTT Positron Emission Tomography for the Measurement of PARP Tumor Expression in Patients With Metastatic Breast Cancer

NCT06502691 · University of Washington
In plain English

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Official title
[18F]FTT Positron Emission Tomography (PET) in Patients With Metastatic Breast Cancer
About this study
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.
Eligibility criteria
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) performance status 0-2 * Archival tissue (formalin-fixed paraffin-embedded \[FFPE\]) from at least one metastatic site biopsy should be available prior to study enrollment; if archival tissue is not available, then a metastatic site biopsy will be required during the study screening period * Patient must be willing to proceed with an on-treatment biopsy of metastatic site if an on-treatment \[18F\]FTT PET will be performed (at 12 ± 4 weeks after starting PARP inhibitor ± ICI treatment) * For women of childbearing potential, a negative serum pregnancy test is required within 7 days prior to \[18F\]FTT PET imaging on day 1. For women who obtain on-treatment (12-week) \[18F\]FTT imaging, a negative serum pregnancy test will be required within 7 days prior to \[18F\]FTT PET imaging * Men and women of reproductive potential need to agree to employ two highly effective and acceptable forms of contraception throughout their participation in the study * Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations * Ability to understand and the willingness to sign a written informed consent document. Informed consent must be provided prior to any study specific procedures Exclusion Criteria: * 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 * Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of PARP inhibitor therapy (per investigator's discretion)
Study design
Enrollment target: 22 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-02-26
Estimated completion: 2030-12-31
Last updated: 2026-03-02
Interventions
Other: Best PracticeProcedure: Biopsy of BreastProcedure: Computed TomographyOther: Electronic Health Record ReviewOther: Fludeoxyglucose F-18Radiation: Fluorine F 18 FluorthanatraceDrug: Immune Checkpoint InhibitorDrug: Poly (ADP-Ribose) Polymerase InhibitorProcedure: Positron Emission TomographyProcedure: Positron Emission Tomography
Primary outcomes
  • Overall response rate (ORR) (Baseline up to 6 months)
Sponsor
University of Washington · other
With: Breast Cancer Research Foundation
Contacts & investigators
ContactJennifer Specht, MD · contact · jspecht@uw.edu · 206-606-6889
InvestigatorJennifer Specht, MD · principal_investigator, Fred Hutch/University of Washington Cancer Consortium
All locations (1)
Fred Hutch/University of Washington Cancer ConsortiumRecruiting
Seattle, Washington, United States
[18F]FTT Positron Emission Tomography for the Measurement of PARP Tumor Expression in Patients With Metastatic Breast Cancer · TrialPath