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This combination therapy consists of the immune checkpoint inhibitor nivolumab, endocrine (hormone) therapy, and palliative radiation therapy. It was specifically evaluated in Cohort A of a Phase Ib/II clinical trial (KBCRN-B13) conducted by the Kyoto Breast Cancer Research Network for the treatment of hormone receptor-positive (luminal-like), HER2-negative metastatic breast cancer with bone metastases. Nivolumab is a monoclonal antibody that targets the PD-1 receptor to restore T-cell anti-tumor activity. The regimen combines this immunotherapy with standard endocrine therapy and a single 8 Gy fraction of radiation to bone metastases, aiming to trigger an abscopal effect and improve systemic disease control. Results from Cohort A demonstrated that the combination is safe with modest clinical activity, showing an objective response rate of 11% and a disease control rate of 39%.
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