eligibility_summary
Eligible: women 18–75 with newly treated HER2+ invasive breast cancer (T1c–3 N0–1 M0 or T2–3 N2/3 M0), ECOG 0–1, planned curative surgery, adequate marrow/hepatic/renal function, LVEF≥55, QTcF<470, contraception and consent. Exclude: drug allergy, prior anticancer therapy/radiation (except cured cervical CIS/basal cell), recent major non-breast surgery, stage IV, drug absorption issues, serious cardiac/psychiatric, pregnant/lactating, severe organ/blood disease, investigator deems unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06537674 tests neoadjuvant pyrotinib plus trastuzumab for HER2-positive early breast cancer, comparing trastuzumab given subcutaneously vs intravenously. Drugs and mechanisms: Pyrotinib—oral small‑molecule, irreversible pan‑ERBB tyrosine kinase inhibitor (EGFR/HER1, HER2, HER4) that blocks receptor phosphorylation and downstream PI3K/AKT/mTOR and RAS/RAF/MEK/ERK signaling, suppressing proliferation and survival. Trastuzumab—humanized IgG1 monoclonal antibody (immunotherapy) targeting the HER2 extracellular domain, inhibits HER2 signaling/dimerization and receptor shedding, and induces antibody‑dependent cellular cytotoxicity via FcγR+ immune cells (e.g., NK cells). Targets: HER2‑overexpressing breast cancer cells, ERBB receptor pathway, downstream PI3K/AKT and MAPK cascades, immune effector engagement through ADCC. The antibody is identical in both arms, only route (SC vs IV) differs.