eligibility_summary
Include: adults ≥18 with TNBC (ER/PR ≤10%) and extracranial breast cancer with brain mets, SRS-eligible, measurable brain lesion(s) ≥0.5 cm (largest ≤4 cm), ECOG 0–2, prior taxane+anthracycline, stable steroids ≤8 mg/d, contraception and negative pregnancy tests. Exclude: leptomeningeal disease, pregnancy/breastfeeding, HIV viremia, active autoimmune (limited exceptions), pneumonitis/ILD, significant cardiac disease, oxygen use, infection, IBD/GI perforation, other cancers (unless remission ≥2y), recent surgery/therapy, prior topo‑1 for brain mets, investigational drugs, active HBV/HCV, drug allergy, prisoners/detained.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I/II NCT06238921 tests sacituzumab govitecan (SG) plus zimberelimab with stereotactic radiosurgery (SRS) vs SG alone in metastatic triple‑negative breast cancer with brain metastases. SG (Trodelvy) is an antibody‑drug conjugate targeting Trop‑2 on tumor cells, delivering SN‑38 (a topoisomerase I inhibitor) to cause DNA damage and cytotoxicity. Zimberelimab is an anti‑PD‑1 IgG4 monoclonal antibody (immune checkpoint inhibitor) that blocks PD‑1 on T cells to restore antitumor immunity. SRS delivers focal high‑dose radiation to brain lesions, inducing DNA double‑strand breaks and immunogenic cell death. Targets/pathways: Trop‑2–positive tumor cells, topoisomerase I, PD‑1/PD‑L1 axis, and radiation‑triggered antigen release in the brain tumor microenvironment.