eligibility_summary
Eligible: females 18–70 with histology‑confirmed stage I–II, node‑negative HER2+ cancer (tumor 1–5 cm, bilateral allowed if both meet), adequate marrow/liver/renal function, LVEF >50%, and consent. Exclude: prior neoadjuvant therapy, other malignancy (except basal cell/cervical in situ), stage IV, pregnancy/lactation/no contraception, other trials, severe organ dysfunction or recent major cardiac/cerebrovascular disease, uncontrolled DM/HTN/infection, substance/psych disorders, or deemed unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III, open-label adjuvant trial in node-negative, HER2+ invasive breast cancer comparing pyrotinib + trastuzumab + paclitaxel vs trastuzumab + paclitaxel. Pyrotinib: small-molecule, irreversible pan-ErbB tyrosine kinase inhibitor (EGFR/HER1, HER2, HER4) that suppresses downstream PI3K/AKT and RAS/MAPK signaling. Trastuzumab: humanized IgG1 monoclonal antibody against the HER2 extracellular domain, blocks HER2 signaling/dimerization and triggers Fc-mediated ADCC. Paclitaxel: taxane cytotoxic that stabilizes microtubules, causing mitotic arrest. Targets: HER2-overexpressing breast cancer cells, ErbB/HER2 pathway and downstream survival/proliferation cascades, immune effector (NK cell) ADCC, mitotic spindle/microtubules.