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

Launched by UNIVERSITY OF WASHINGTON · Jul 8, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new imaging technique called positron emission tomography (PET) using a special substance called \[18F\]FTT to help doctors better see and understand how metastatic breast cancer responds to treatment. Metastatic breast cancer is cancer that has spread from the breast to other parts of the body. The trial focuses on patients who are receiving standard treatments known as PARP inhibitors, which help stop cancer cells from repairing themselves, and may also include immune checkpoint inhibitors that boost the body’s immune response against cancer. By using \[18F\]FTT with PET scans, researchers hope to see if this method can accurately locate and visualize cancer cells that express a protein called PARP1, potentially leading to improved monitoring of treatment effectiveness.

To participate in this trial, patients should be at least 18 years old and have a confirmed diagnosis of invasive breast cancer that has spread. They must be eligible for treatment with PARP inhibitors, either alone or with immune checkpoint inhibitors, and have measurable cancer lesions that can be assessed. Participants will undergo imaging and may need to provide tissue samples from their tumors. Women who can become pregnant must have a negative pregnancy test before imaging and agree to use effective birth control during the study. Overall, this trial aims to enhance our understanding of how well these treatments are working in patients with advanced breast cancer, which could help improve future care.

Gender

ALL

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)