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.
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
Prior immunotherapy in the past 12 months
Progressing or untreated extra-hepatic metastatic disease
Autoimmune disease requiring therapy; immunodeficiency, or any disease process requiring immunosuppressive therapy
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Single group
Biopsy
Procedure/SurgeryUndergo tumor biopsy
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Cemiplimab
Biological/VaccineGiven IV
Computed Tomography
Procedure/SurgeryUndergo CT
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Transarterial Radioembolization
RadiationUndergo TARE
Yttrium Y 90 Resin Microspheres
RadiationGiven intratumorally
CD8+ T cell infiltration in tumor microenvironment (TME): baseline
Will be analyzed using multiplex immunofluorescence (IF) of formalin-fixed paraffin-embedded (FFPE) tissue. Will estimated the mean and standard deviation of the percent change.
CD8+ T cell infiltration in tumor microenvironment (TME): post TARE -1 (day 21)
Will be analyzed using multiplex immunofluorescence (IF) of formalin-fixed paraffin-embedded (FFPE) tissue. Will estimated the mean and standard deviation of the percent change.
CD8+ T cell infiltration in tumor microenvironment (TME): prior to TARE-2 (day 42)
Will be analyzed using multiplex immunofluorescence (IF) of formalin-fixed paraffin-embedded (FFPE) tissue. Will estimated the mean and standard deviation of the percent change.
Incidence of adverse events
Will be assessed and graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
T cell activation in TME: baseline
Will be analyzed using multiplex IF of FFPE.
T cell activation in TME: post-TARE-1 (day 21)
Will be analyzed using multiplex IF of FFPE.
T cell activation in TME: prior to TARE-2 (Day 42)
Will be analyzed using multiplex IF of FFPE.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
