eligibility_summary
Eligible: female 18–75, ECOG 0–1, pathologic HER2+ early/locally advanced breast cancer with T≥2 cm or node+, ER≥10%, adequate organ function (blood counts, LFTs, renal CrCl≥50, LVEF≥55%, QTcF<470), use contraception if childbearing, consent. Exclude: stage IV/inflammatory, prior anti-cancer/radiation, other trial therapy, recent major non-breast surgery, serious cardiac disease, GI absorption issues, drug allergy, immunodeficiency/HIV/transplant, pregnant/nursing/unwilling contraception, severe comorbidity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm neoadjuvant study in ER+/HER2+ early/locally advanced breast cancer testing TCHpy: 1) Pyrotinib—oral, irreversible pan-HER small-molecule TKI (EGFR/HER1, HER2, HER4) blocking downstream PI3K/AKT/mTOR and RAS/RAF/MEK/ERK signaling to inhibit proliferation. 2) Trastuzumab—humanized anti-HER2 monoclonal antibody that blocks HER2 signaling/dimerization and triggers ADCC via NK cells. 3) Albumin-bound paclitaxel (nab-paclitaxel)—taxane chemotherapy stabilizing microtubules to arrest mitosis. 4) Carboplatin—platinum agent causing DNA crosslinks leading to apoptosis. Targets: HER2-overexpressing tumor epithelial cells, HER family receptors, downstream survival/proliferation pathways, microtubules/mitotic machinery, DNA replication/repair, with immune effector engagement via ADCC.