Status:
RECRUITING
[18F]FTT Positron Emission Tomography for the Measurement of PARP Tumor Expression in Patients With Metastatic Breast Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Breast Cancer Research Foundation
Conditions:
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 star...
Detailed 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 a...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06502691
Start Date
January 1 2026
End Date
December 31 2030
Last Update
December 3 2025
Active Locations (1)
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1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109