eligibility_summary
Inclusion: Adults 18–75 with HER2+ recurrent/metastatic breast cancer, measurable disease or bone-only, ECOG 0–1, adequate organ function, LVEF ≥50%, QTcF <470 ms. Exclusion: prior systemic therapy for metastasis or anti‑HER (except adjuvant trastuzumab), relapse <12 mo after adjuvant, active brain mets, ≥G3 neuropathy, serious cardiac/HTN, uncontrolled effusions, pregnancy, immunodeficiency, active infection/hepatitis, endocrine therapy within 7 d.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests two oral doses of pyrotinib (320 mg vs 400 mg daily, q3w) combined with trastuzumab (8 mg/kg then 6 mg/kg q3w, IV) and taxane chemotherapy (docetaxel 75 mg/m2 q3w) as first-line therapy for HER2-positive advanced breast cancer. Drug types and mechanisms: • Pyrotinib: small-molecule, irreversible pan-ErbB tyrosine kinase inhibitor that blocks EGFR/HER1, HER2, and HER4 ATP sites, suppressing downstream MAPK and PI3K/AKT signaling. • Trastuzumab: humanized IgG1 monoclonal antibody targeting HER2 extracellular domain, inhibits receptor signaling/dimerization and mediates antibody-dependent cellular cytotoxicity (ADCC). • Docetaxel: cytotoxic taxane that stabilizes microtubules, causing mitotic arrest and apoptosis. Targets: HER2-overexpressing breast cancer cells, EGFR/HER2/HER4 pathways and downstream PI3K/AKT and MAPK cascades, microtubules in proliferating tumor cells, FcγR-expressing immune effector cells (NK cells) via ADCC.