Anatomic Stage IV Breast Cancer AJCC v8Phase 1/2NCT06502691
[18F]FTT Positron Emission Tomography for the Measurement of PARP Tumor Expression in Patients With Metastatic Breast Cancer
A Phase 1/2 study testing Best Practice, Biopsy of Breast and Computed Tomography in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by University of Washington at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
- What is being tested?
- Best Practice, Biopsy of Breast and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2026to 31 Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Jennifer Specht, MD, 206-606-6889, jspecht@uw.edu
Jennifer Specht, MD
About this study
Official title: [18F]FTT Positron Emission Tomography (PET) in Patients With Metastatic Breast Cancer
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.
Read the 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.
- Being tested
- Best Practice, Biopsy of Breast, Computed Tomography, Electronic Health Record Review, Fludeoxyglucose F-18
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive of standard care
Biopsy of BreastProcedure or surgery
Also called Breast Biopsy
Undergo breast biopsy
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo FDG PET/CT
Electronic Health Record ReviewOther
Ancillary studies
Fludeoxyglucose F-18Other
Also called 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18
Given FDG
Fluorine F 18 FluorthanatraceRadiation
Also called [18F]FluorThanatrace, [18F]FTT, FLUORTHANATRACE F-18
Given IV
Immune Checkpoint InhibitorDrug
Also called ICI
Receive ICI treatment
Poly (ADP-Ribose) Polymerase InhibitorDrug
Also called PARP Inhibitor, Poly(ADP-Ribose) Polymerase Inhibitor
Receive PARP inhibitor treatment
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo [18F]FTT PET
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo FDG PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI) | Experimental | Patients receive [18F]FTT 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/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening and during follow up. Receives: Other: Best Practice; Procedure: Biopsy of Breast; Procedure: Computed Tomography; Other: Electronic Health Record Review; Other: Fludeoxyglucose F-18; Radiation: Fluorine F 18 Fluorthanatrace; Drug: Immune Checkpoint Inhibitor; Drug: Poly (ADP-Ribose) Polymerase Inhibitor; Procedure: Positron Emission Tomography |
| Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI) | Active comparator | 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. Receives: Other: Best Practice; Procedure: Biopsy of Breast; Procedure: Computed Tomography; Other: Electronic Health Record Review; Other: Fludeoxyglucose F-18; Radiation: Fluorine F 18 Fluorthanatrace; Drug: Immune Checkpoint Inhibitor; Drug: Poly (ADP-Ribose) Polymerase Inhibitor; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria on poly (ADP-ribose) polymerase (PARP) inhibitor ± immune checkpoint inhibitor (ICI) treatment. Will use a boxplot to illustrate the difference of standard uptake value (SUV)max and SUVmean between responders and non-responders.
Measured: Baseline up to 6 months
Secondary outcomes (1)
ORR
Will be assessed using RECIST 1.1 criteria on PARP inhibitor ± ICI treatment. Will use the nonparametric method Wilcoxon Rank Sum test to evaluate the difference of the changes of SUVmax and/or SUVmean between responders and non-responders.
Measured: Baseline up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start26 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage IV Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Sponsor
- Investigators
- Jennifer Specht, MD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502691
- Sponsor's protocol ID
- RG1124440
- Other IDs
- NCI-2024-04929, FHIRB0020495
- Status last verified
- May 2026
- First submitted
- 8 Jul 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F]FTT Positron Emission Tomography (PET) in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06502691
- Acronym / sponsor ID
- RG1124440
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI) | Experimental | Other: Best Practice, Procedure: Biopsy of Breast, Procedure: Computed Tomography, Other: Electronic Health Record Review, Other: Fludeoxyglucose F-18, Radiation: Fluorine F 18 Fluorthanatrace, Drug: Immune Checkpoint Inhibitor, Drug: Poly (ADP-Ribose) Polymerase Inhibitor, Procedure: Positron Emission TomographyPatients receive [18F]FTT 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/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 ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI) | Active comparator | Other: Best Practice, Procedure: Biopsy of Breast, Procedure: Computed Tomography, Other: Electronic Health Record Review, Other: Fludeoxyglucose F-18, Radiation: Fluorine F 18 Fluorthanatrace, Drug: Immune Checkpoint Inhibitor, Drug: Poly (ADP-Ribose) Polymerase Inhibitor, Procedure: Positron Emission TomographyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive of standard care | Other | Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI), Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI) |
| Biopsy of BreastAlso: Breast BiopsyUndergo breast biopsy | Procedure or surgery | Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI), Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo FDG PET/CT | Procedure or surgery | Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI), Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI) |
| Electronic Health Record ReviewAncillary studies | Other | Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI), Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI) |
| Fludeoxyglucose F-18Also: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18Given FDG | Other | Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI), Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI) |
| Fluorine F 18 FluorthanatraceAlso: [18F]FluorThanatrace, [18F]FTT, FLUORTHANATRACE F-18Given IV | Radiation | Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI), Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI) |
| Immune Checkpoint InhibitorAlso: ICIReceive ICI treatment | Drug | Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI), Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI) |
| Poly (ADP-Ribose) Polymerase InhibitorAlso: PARP Inhibitor, Poly(ADP-Ribose) Polymerase InhibitorReceive PARP inhibitor treatment | Drug | Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI), Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo [18F]FTT PET | Procedure or surgery | Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI), Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo FDG PET/CT | Procedure or surgery | Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI), Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI) |
Primary outcome
Overall response rate (ORR)
Time frame: Baseline up to 6 months
Will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria on poly (ADP-ribose) polymerase (PARP) inhibitor ± immune checkpoint inhibitor (ICI) treatment. Will use a boxplot to illustrate the difference of standard uptake value (SUV)max and SUVmean between responders and non-responders.
1 secondary outcome
ORR
Time frame: Baseline up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Specht, MD principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Best Practice, Biopsy of Breast and Computed Tomography in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Specht, MD (206-606-6889, jspecht@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: Baseline up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.