PET Imaging for Breast Cancer

Overseen By Jennifer Specht, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Washington

Must be taking: PARP inhibitors

Disqualifiers: Myelodysplastic syndrome, Acute myeloid leukemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

22 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method to evaluate its ability to detect active cancer cells in individuals with breast cancer that has metastasized. The focus is on using a special PET scan with a tracer called \[18F\]FTT, which targets cancer cells undergoing certain treatments. Participants should have metastatic breast cancer and be receiving PARP inhibitors (Poly (ADP-Ribose) Polymerase Inhibitors), either alone or with immune therapy. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and to measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get a clear answer.

What prior data suggests that this PET imaging technique is safe for breast cancer patients?

Previous studies have shown that drugs called PARP inhibitors are generally well-tolerated by patients. Common side effects include nausea, fatigue, and anemia, which is a low red blood cell count. Among these drugs, olaparib is known for its mild side effects.

Research into immune checkpoint inhibitors (ICI) indicates that they are also generally safe but can cause some side effects. These may include fatigue, skin rash, and inflammation in different parts of the body. Most people handle these treatments well, though they can sometimes lead to more serious immune-related issues.

Both types of treatments are used in cancer care and have been studied in various settings, including breast cancer. While side effects can occur, many patients manage these treatments without significant problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines advanced PET imaging techniques with PARP inhibitors to enhance breast cancer diagnosis and treatment monitoring. Unlike standard imaging methods, this trial uses [18F]FTT PET scans that may provide more detailed insights into how the cancer responds to treatment at the molecular level. This approach could potentially allow for more personalized treatment adjustments and quicker assessments of treatment effectiveness, giving patients a better chance at successful outcomes.

What evidence suggests that this trial's imaging techniques could be effective for detecting metastatic breast cancer?

This trial will evaluate the use of PET imaging in breast cancer treatment. Participants will receive a Poly (ADP-Ribose) Polymerase (PARP) inhibitor, which has been found to help patients with BRCA-mutated breast cancer live longer without disease progression. These drugs block a protein that repairs cell damage, leading to cancer cell death.

Another treatment option in this trial is the use of Immune Checkpoint Inhibitors (ICI), which have proven effective, especially for patients with triple-negative breast cancer. These drugs help the immune system attack cancer cells, and studies have shown that about 50% of patients respond to them. Both treatments work in different ways, and using them together in this trial might lead to better outcomes. ^{3 6 7 8 9}

Who Is on the Research Team?

Jennifer Specht, MD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for patients with breast cancer that has spread to other body parts. Participants must be receiving standard PARP inhibitors, which are drugs targeting specific enzymes in cancer cells, and may also be getting immune checkpoint inhibitors as part of their usual care.

Inclusion Criteria

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

I am willing to have a biopsy if I undergo a specific PET scan during my treatment.

My breast cancer has spread to other parts of my body.

Exclusion Criteria

Pregnant or breastfeeding women

I have had myelodysplastic syndrome or acute myeloid leukemia.

I can swallow pills and do not have stomach issues affecting medication absorption.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Initial Imaging and Treatment Initiation

Participants receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy

1 day

1 visit (in-person)

Follow-up Imaging

Participants undergo follow-up PET/CT scans at 12 weeks and 6 months, with potential tissue biopsies

6 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Immune Checkpoint Inhibitor
• Poly (ADP-Ribose) Polymerase Inhibitor

Trial Overview [18F]FTT PET scans are being tested to see if they can better detect tumor cells in metastatic breast cancer patients undergoing treatment with PARP inhibitors, alone or combined with immune checkpoint inhibitors. The scan uses a special dye that highlights active tumor cells on imaging.

How Is the Trial Designed?

Group I: Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI) Experimental Treatment 9 Interventions

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.

Group II: Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI) Active Control 9 Interventions

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.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Breast Cancer Research Foundation

Collaborator

Trials

79

Recruited

40,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11542155/

Real‑world evaluation of the efficacy of immune checkpoint ... In the first-line therapy group, the ICI-based therapy was effective in half of the patients (50.0%; 12/24), as evidenced by the corresponding ORR of 50.0%. In ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e13131

Immune checkpoint inhibitor (ICI) efficacy in triple-negative ... This meta-analysis synthesizes findings from clinical trials evaluating the efficacy of ICIs in TNBC-LM pts.

3. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2822926

Neoadjuvant Immune Checkpoint Inhibitors Plus ... In this meta-analysis involving 5114 patients, neoadjuvant ICI therapy was associated with improved efficacy outcomes in early-stage triple-negative breast ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0960977625006034

Baseline Tumour Burden and Prognosis in Breast Cancer ... These results suggest that ICI treatment will be most effective in patients with lower tumour burden. Key words. tumour burden. advanced breast ...

5. nature.com nature.com/articles/s41591-024-03398-5

Prediction of checkpoint inhibitor immunotherapy efficacy ... In this study, we explored whether a machine learning system could predict ICI outcomes using routine blood tests and standard clinical variables.

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e14621

Adverse events and tolerability of immune checkpoint ... This systematic review and meta-analysis provides extensive data on the safety of ICI toxicity in early-stage BC patients across clinical trials.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10260715/

Immune Checkpoint Inhibitors in Breast Cancer: A Narrative ... In this paper, we review the clinical evidence for the use of ICIs in breast cancer, in both the metastatic as well as neoadjuvant/adjuvant setting.

8. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1665716/full

Safety of immune checkpoint inhibitors for cancer treatment Our study provides one of the largest real-world analyses of ICI safety outcomes in a cohort from the Middle East. The findings on the incidence and spectrum of ...

9. nature.com nature.com/articles/s41523-023-00508-3

Immunotherapy in breast cancer: an overview of current ... This review provides an overview of immunotherapies currently under clinical development and updated key results from clinical trials.