eligibility_summary
Eligible: adults ≥18 with histologically confirmed HER2+ early/locally advanced breast cancer (AJCC 8th), ECOG 0–1, adequate organ/bone marrow, willing for neoadjuvant therapy, surgery, and contraception. Exclude: inflammatory/bilateral disease, recent other cancers, prior breast therapy/RT, surgery contraindications/recent major surgery, drug/steroid allergies, immunodeficiency/HIV, serious cardiac/infections, strong CYP3A4 modulators, pregnancy/lactation, other trials, or poor compliance risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Experimental—KN026 + HB1801 ± carboplatin, Comparator—trastuzumab + pertuzumab + docetaxel ± carboplatin. Mechanisms/types: KN026 is a HER2‑targeted bispecific IgG1 monoclonal antibody that binds two non‑overlapping HER2 epitopes (trastuzumab‑ and pertuzumab‑like), blocking HER2 dimerization and signaling and inducing ADCC. HB1801 is an investigational drug, the registry does not specify its class or mechanism. Trastuzumab (anti‑HER2 IgG1) inhibits HER2 signaling and mediates ADCC. Pertuzumab (anti‑HER2 IgG1) blocks HER2 dimerization and mediates ADCC. Docetaxel (taxane) stabilizes microtubules, causing mitotic arrest. Carboplatin (platinum) forms DNA crosslinks. Cells/pathways targeted: HER2‑overexpressing breast cancer cells, HER2 receptor dimerization and downstream PI3K/AKT/MAPK signaling, microtubule dynamics, DNA replication/repair, and Fc‑gamma receptor–mediated ADCC by immune effector cells.