Cemiplimab + Y-90 SIR-Spheres for Liver Metastases from Breast Cancer

This trial explores a new treatment approach for breast cancer that has spread to the liver. It combines cemiplimab, a drug that may help the immune system attack cancer cells, with a targeted radiation treatment called TARE using Y90 SIR-Spheres (tiny radioactive spheres). This combination aims to kill or slow the growth of cancer in the liver. Individuals with breast cancer that has spread to the liver and who have already tried chemotherapy might be suitable candidates for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have received any anticancer therapy within 28 days before the first dose of the study drug, and certain medications like immunosuppressive drugs are not allowed. It's best to discuss your specific medications with the study team.

Previous studies have found cemiplimab, a type of immunotherapy, to be generally safe. Among 60 patients with advanced solid tumors, no serious side effects occurred, indicating a positive safety profile. However, 91% of patients experienced treatment-related side effects, mostly mild.

For Y-90 SIR-Spheres used in transarterial radioembolization (TARE), research has shown that this treatment is usually well-tolerated. It proved safe for patients with breast cancer that had spread to the liver, with most experiencing no severe side effects. Additionally, the treatment controlled liver disease in about 70% of cases.

Researchers are excited about using cemiplimab combined with Y-90 SIR-Spheres for liver metastases from breast cancer because it represents a novel approach by pairing immunotherapy with targeted radiation. Cemiplimab is an immune checkpoint inhibitor that unleashes the body's immune system to attack cancer cells, a mechanism different from traditional chemotherapy. The Y-90 SIR-Spheres deliver precise radiation directly to the tumor, minimizing damage to surrounding healthy tissue. This combination aims to enhance the treatment's efficacy while potentially reducing side effects compared to conventional therapies.

Research has shown that cemiplimab, a monoclonal antibody, effectively aids individuals with various cancers. In some studies, cemiplimab significantly reduced the risk of cancer recurrence or death, with one study indicating a 68% reduction. Additionally, transarterial radioembolization (TARE) using Y-90 SIR-Spheres has shown promise in managing liver tumors, achieving a 70% success rate in controlling cancer in patients with breast cancer that has spread to the liver. In this trial, participants will receive both cemiplimab and TARE as part of the treatment regimen. Cemiplimab enhances the immune system's ability to fight cancer, while TARE delivers targeted radiation to the tumors. Together, these treatments aim to destroy tumors more effectively and improve patient outcomes.²³⁴⁵⁶