eligibility_summary
Eligibility: Adults ≥18 with recurrent/metastatic HER2‑positive breast cancer (central lab), no prior systemic therapy for metastatic disease, ECOG 0–1, measurable disease (RECIST 1.1), adequate organ/bone marrow, informed consent. Exclusions: ineligible for study drugs, untreated/unstable brain/spinal mets, cord compression, or carcinomatous encephalitis, pregnant/lactating, or clinically significant conditions (e.g., psychiatric/substance) interfering with participation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05838066 (Phase 3) tests first-line KN026 + HB1801 vs trastuzumab + pertuzumab + docetaxel in HER2-positive recurrent/metastatic breast cancer. Drugs/mechanisms: • KN026: recombinant humanized bispecific anti‑HER2 IgG monoclonal antibody binding two distinct HER2 epitopes to block HER2 homo/heterodimerization and signaling, also mediates Fcγ‑dependent ADCC. • HB1801: investigational IV drug (mechanism not specified in the record). • Trastuzumab: anti‑HER2 IgG mAb (domain IV) inhibiting signaling and inducing ADCC. • Pertuzumab: anti‑HER2 IgG mAb (domain II) preventing HER2 dimerization and inducing ADCC. • Docetaxel: taxane chemotherapeutic that stabilizes microtubules, causing mitotic arrest. Targets/pathways: HER2/ERBB2 on tumor cells, blockade of HER2 dimerization and downstream PI3K/AKT/MAPK signaling, immune effector ADCC, microtubule dynamics in dividing cells.