eligibility_summary
Eligible: ≥18, histologically confirmed early breast cancer (T1cN1–2 or T2–4N0–2), ER/PR <1% or 1–10% and HER2−, started KN‑522 (pembrolizumab + paclitaxel/carboplatin), ECOG 0–1, no tumor shrinkage after part 1, negative pregnancy test/contraception, willing biopsy, adequate organ function. Exclude: stage IV, prior therapy, pregnancy, GI/colitis, active autoimmune/immunosuppression, recent major cardiac issues, HIV/active HBV/HCV, cognitive impairment, major comorbidities, live vaccine ≤30 d.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II neoadjuvant single-arm trial in early-stage TNBC resistant to prior immunochemotherapy. Interventions: 1) Sacituzumab govitecan—an antibody–drug conjugate (ADC) targeting Trop-2, upon binding/internalization it releases SN-38 (topoisomerase I inhibitor), causing DNA damage and tumor cell death, with a bystander effect. 2) Pembrolizumab—an anti–PD-1 IgG4 monoclonal antibody immune checkpoint inhibitor that blocks PD-1 interaction with PD-L1/PD-L2 to restore antitumor T-cell activity. Targets: Trop-2–expressing tumor cells, topoisomerase I/DNA replication, and the PD-1/PD-L1 immune checkpoint on T cells/tumor cells.