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PARP Inhibitor

PET Imaging for Breast Cancer

Phase 1 & 2

Waitlist Available

Led By Shaveta Vinayak

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically confirmed invasive breast cancer with metastatic disease

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

Must not have

Patients with prior myelodysplastic syndrome or acute myeloid leukemia due to rare risk associated with PARP inhibitor therapy

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how well a specific imaging technique called fluorine F 18 fluorthanatrace (18F]FTT) positron emission tomography (PET) works in detecting

Who is the study for?

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.

What is being tested?

[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.

What are the potential side effects?

Potential side effects include reactions to the [18F]FTT tracer used during the PET scan, such as allergic reactions or discomfort at the injection site. Standard treatments like PARP inhibitors and ICIs have their own side effects ranging from nausea to blood count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have a tumor that can be measured by scans.

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I am 18 years old or older.

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I can do most activities by myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had myelodysplastic syndrome or acute myeloid leukemia.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate (ORR)

Secondary study objectives

ORR

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)Experimental Treatment9 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 Control9 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Immune Checkpoint Inhibitor

2019

Completed Phase 2

~40

Biopsy of Breast

2012

N/A

~90