OncoMatch/Clinical Trials/NCT06860815
Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Breast Cancer
Is NCT06860815 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cemiplimab for anatomic stage iv breast cancer ajcc v8.
Treatment: Cemiplimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy — metastatic
previously treated with ≥ 1 line of chemotherapy in metastatic setting
Cannot have received: immunotherapy
Exception: in the past 12 months
Prior immunotherapy in the past 12 months
Cannot have received: anti-PD-1 therapy (cemiplimab)
Exception: in the past 12 months
Prior exposure to anti-PD-1/PD-L1 inhibitor or anti-CTLA4 inhibitor, including cemiplimab in the past 12 months
Cannot have received: anti-PD-L1 therapy
Exception: in the past 12 months
Prior exposure to anti-PD-1/PD-L1 inhibitor or anti-CTLA4 inhibitor, including cemiplimab in the past 12 months
Cannot have received: anti-CTLA-4 therapy
Exception: in the past 12 months
Prior exposure to anti-PD-1/PD-L1 inhibitor or anti-CTLA4 inhibitor, including cemiplimab in the past 12 months
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1500/uL; Platelet count ≥ 75000/uL; INR ≤ 1.6
Kidney function
Measured creatinine clearance (CL) > 40 mL/min or calculated creatinine CL > 40 mL/min
Liver function
Total bilirubin < 2.0mg/dL; AST/ALT ≤ 5 x ULN; Albumin ≥ 2.8 g/dL; No radiographic or clinical evidence of cirrhosis
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1500/uL; Platelet count ≥ 75000/uL; Total bilirubin < 2.0mg/dL; AST/ALT ≤ 5 x ULN; Albumin ≥ 2.8 g/dL; INR ≤ 1.6; Measured creatinine clearance (CL) > 40 mL/min or calculated creatinine CL > 40 mL/min; No radiographic or clinical evidence of cirrhosis
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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