[18F]FTT Positron Emission Tomography for the Measurement of PARP Tumor Expression in Patients With Metastatic Breast Cancer

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.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Metastatic Breast Carcinoma

Interventions

OTHER

Best Practice

Receive of standard care

PROCEDURE

Biopsy of Breast

Undergo breast biopsy

PROCEDURE

Computed Tomography

Undergo FDG PET/CT

OTHER

Electronic Health Record Review

Ancillary studies

OTHER

Fludeoxyglucose F-18

Given FDG

RADIATION

Fluorine F 18 Fluorthanatrace

Given IV

DRUG

Immune Checkpoint Inhibitor

Receive ICI treatment

DRUG

Poly (ADP-Ribose) Polymerase Inhibitor

Receive PARP inhibitor treatment

PROCEDURE

Positron Emission Tomography

Undergo \[18F\]FTT PET

PROCEDURE

Positron Emission Tomography

Undergo FDG PET/CT

Sponsors & Collaborators

• Breast Cancer Research Foundation

  collaborator OTHER

• University of Washington

  lead OTHER

Principal Investigators

• Jennifer Specht, MD · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-26

Primary Completion

2027-12-31

Completion

2030-12-31

FDA Drug

Yes

Countries

• United States

Study Locations