eligibility_summary
Eligibility: ≥18, ER/PR ≤10% and HER2‑low (IHC1+ or 2+/ISH–) advanced breast cancer, ≥1 prior line incl taxane/anthracycline, measurable disease, ECOG 0–1, negative pregnancy test/contraception, adequate marrow/liver/renal/coagulation, LVEF ≥50%. Exclude: active CNS mets, prior anti‑HER2 ADC, autoimmune disease (exceptions apply), recent immunosuppression, other malignancy, severe prior ADC/irAEs, interstitial pneumonia, major cardiac disease, active infection/fever, live vaccine <4 wks, substance abuse.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm trial in HER2-low metastatic breast cancer testing: 1) SHR-A1811: a HER2-targeted antibody–drug conjugate (ADC). Mechanism: binds HER2 on tumor cells, undergoes receptor-mediated internalization, and releases an intracellular cytotoxic payload to induce tumor cell death (potential bystander killing if payload is membrane-permeable). 2) Adebrelimab: an anti–PD-L1 monoclonal antibody (immune checkpoint inhibitor). Mechanism: blocks PD-L1 to restore PD-1–mediated T-cell activation and antitumor immunity. Cells/pathways targeted: HER2 on breast cancer cells, PD-1/PD-L1 checkpoint on tumor and immune cells, enhancing cytotoxic T-lymphocyte activity alongside direct HER2+ tumor killing.