Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Breast Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: City of Hope Medical Center
You may qualify if…
- ✓ 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. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
You may not qualify if…
- ✕ 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
- ✕ Portal vein invasion
- ✕ Evidence of diffuse metastatic disease (tumor burden occupying \> 50% of liver)
- ✕ Major surgical procedure (as defined by the investigator) within 28 days prior to radioembolization. Note: Local surgery of isolated lesions for palliative intent is acceptable
- ✕ Participation in another clinical study with an investigational product during the last 4 weeks
Where it's recruiting
Duarte
Source: ClinicalTrials.gov · NCT06860815 · last updated 2026-05-20