eligibility_summary
Adults (≥18) with histologically confirmed HER2+ (IHC3+ or 2+/ISH+), ER/PR– invasive breast cancer, early/locally advanced (AJCC 8: T2–3 N0–1 M0, T2–3 N2–3 M0, or T4 any N M0), ECOG 0–1, tumor >2 cm, planned neoadjuvant then surgery, LVEF ≥55%, adequate organ function, contraception/neg pregnancy. Exclude stage IV, inflammatory/bilateral, prior BC therapy, recent major surgery/other trials, other cancers, immunodeficiency, serious CV, uncontrolled illness, substance abuse, neuropsych, pregnancy, investigator concern.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3, double-blind, equivalence neoadjuvant trial in early/locally advanced HER2+, HR– breast cancer compares SYSA1901 (a pertuzumab biosimilar, humanized anti-HER2 monoclonal antibody) + trastuzumab (humanized anti-HER2 mAb) + docetaxel (taxane chemotherapy) vs Perjeta (pertuzumab) + trastuzumab + docetaxel. Mechanisms: Pertuzumab/SYSA1901 bind HER2 subdomain II, block ligand-dependent HER2 dimerization (especially HER2/HER3), suppress downstream PI3K/AKT and MAPK signaling, and promote ADCC. Trastuzumab binds HER2 subdomain IV, inhibits ligand-independent signaling, downregulates HER2, and mediates ADCC. Docetaxel stabilizes microtubules, arresting mitosis. Targets: HER2-overexpressing tumor cells (ERBB2), HER2 dimerization and signaling pathways (PI3K/AKT, MAPK), and NK cell–mediated ADCC. Primary endpoint: total pathologic complete response.