Trial Title:
[18F]FTT Positron Emission Tomography for the Measurement of PARP Tumor Expression in Patients With Metastatic Breast Cancer
NCT ID:
NCT06502691
Condition:
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Deoxyglucose
Poly(ADP-ribose) Polymerase Inhibitors
Immune Checkpoint Inhibitors
Fluorodeoxyglucose F18
Fluorides
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive of standard care
Arm group label:
Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Arm group label:
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Procedure
Intervention name:
Biopsy of Breast
Description:
Undergo breast biopsy
Arm group label:
Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Arm group label:
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Other name:
Breast Biopsy
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo FDG PET/CT
Arm group label:
Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Arm group label:
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Arm group label:
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Intervention type:
Other
Intervention name:
Fludeoxyglucose F-18
Description:
Given FDG
Arm group label:
Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Arm group label:
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Other name:
18FDG
Other name:
FDG
Other name:
Fludeoxyglucose (18F)
Other name:
fludeoxyglucose F 18
Other name:
Fludeoxyglucose F18
Other name:
Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
Other name:
Fluorodeoxyglucose F18
Intervention type:
Radiation
Intervention name:
Fluorine F 18 Fluorthanatrace
Description:
Given IV
Arm group label:
Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Arm group label:
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Other name:
[18F]FluorThanatrace
Other name:
[18F]FTT
Other name:
FLUORTHANATRACE F-18
Intervention type:
Drug
Intervention name:
Immune Checkpoint Inhibitor
Description:
Receive ICI treatment
Arm group label:
Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Arm group label:
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Other name:
ICI
Intervention type:
Drug
Intervention name:
Poly (ADP-Ribose) Polymerase Inhibitor
Description:
Receive PARP inhibitor treatment
Arm group label:
Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Arm group label:
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Other name:
PARP Inhibitor
Other name:
Poly(ADP-Ribose) Polymerase Inhibitor
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo [18F]FTT PET
Arm group label:
Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Arm group label:
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo FDG PET/CT
Arm group label:
Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Arm group label:
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
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.
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 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.
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fred Hutch/University of Washington Cancer Consortium
Address:
City:
Seattle
Zip:
98109
Country:
United States
Contact:
Last name:
Shaveta Vinayak
Phone:
206-616-0583
Email:
shaveta@uw.edu
Investigator:
Last name:
Shaveta Vinayak
Email:
Principal Investigator
Start date:
December 1, 2024
Completion date:
December 31, 2029
Lead sponsor:
Agency:
University of Washington
Agency class:
Other
Collaborator:
Agency:
Breast Cancer Research Foundation
Agency class:
Other
Source:
University of Washington
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06502691
