RecruitingPhase 2NCT06860815

Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Breast Cancer

Pilot Study of Cemiplimab and Hepatic Radioembolization in Patients With Liver Dominant Metastatic Breast Cancer


Sponsor

City of Hope Medical Center

Enrollment

11 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining a drug called cemiplimab (an immunotherapy) with a targeted radiation treatment delivered directly into liver blood vessels (Y-90 radioembolization) can help women with breast cancer that has spread to the liver. **You may be eligible if...** - You are 18 or older - You have breast cancer that has spread to the liver - You are in good physical condition (ECOG 0–1) - You have a life expectancy of at least 12 weeks - You are post-menopausal or have a negative pregnancy test **You may NOT be eligible if...** - You are in poor general health (ECOG 2 or higher) - You are pregnant or planning to become pregnant - You have severe heart, liver, or immune system problems that would make the treatments unsafe - You have certain active infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

BIOLOGICALCemiplimab

Given IV

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

RADIATIONTransarterial Radioembolization

Undergo TARE

RADIATIONYttrium Y 90 Resin Microspheres

Given intratumorally


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT06860815


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