City of Hope Medical Center
This phase II trial tests how well cemiplimab and transarterial radioembolization (TARE) with yttrium-90 (Y90) SIR-Spheres, registered trademark, works in treating breast cancer that has spread from where it first started (primary site) to the liver (metastatic). Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. TARE is a treatment that uses radioactive microspheres, such as Y90 SIR-S Spheres, to both cause hepatic artery embolization and to deliver regional radiotherapy. Y90 SIR-S Spheres is an injectable form of the radioisotope yttrium Y 90 encapsulated in resin microspheres. When injected into the artery supplying the tumor, yttrium Y 90 resin microspheres block the tumor blood vessels and deliver the yttrium Y 90 directly to the tumor site, which may kill or slow tumor growth. Giving cemiplimab and Y90 SIR-Spheres by TARE to the tumor in the liver may kill more tumor cells in patients with metastatic breast cancer.
PRIMARY OBJECTIVE: I. To describe the effect of cemiplimab and yttrium Y90 resin microspheres (90Y TARE) on immune activation in the treated tumor based on CD8+ T cells. SECONDARY OBJECTIVES: I. To evaluate other measures of changes (both in treated and untreated lesions after the first TARE treatment) in the tumor microenvironment (TME) of 10 metastatic breast cancer (MBC) patients with liver-dominant disease. II. To identify systemic immune activation in the peripheral blood. III. To determine the safety and tolerability of cemiplimab and hepatic radioembolization in patients with liver…
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative. * Assent, when appropriate, will be obtained per institutional guidelines * Agreement to allow the use of archival tissue from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Age: ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) 0-1 * Must have a life expectancy of at least 12 weeks * Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Wom…
Undergo tumor biopsy
Undergo blood sample collection
Given IV
Undergo CT
Undergo MRI
Undergo TARE
Given intratumorally
Arctuva estimate
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