eligibility_summary
Eligible: women 18–75, ECOG 0–1, HER2+ BC (T1N1–3M0 or T2–4N0M0), normal marrow/liver/renal fxn, LVEF>55%, QTcF<470 ms. Exclude: stage IV or inflammatory BC, prior anti‑tumor Tx/RT (except cured in‑situ/skin), concurrent trial therapy, recent major surgery, serious cardiac disease or uncontrolled HTN, active infection/immunodeficiency/transplant, active HBV/HCV (unless controlled), drug allergy, pregnant/lactating or no contraception, serious comorbidity or per PI.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Single-arm phase 2 neoadjuvant regimen for HER2-positive breast cancer. Interventions and mechanisms: - Pyrotinib: oral small-molecule, irreversible pan-ErbB tyrosine kinase inhibitor (HER1/EGFR, HER2, HER4), blocks HER2/ErbB signaling and downstream PI3K/AKT and RAS/RAF/MEK/ERK pathways. - Trastuzumab: humanized anti-HER2 IgG1 monoclonal antibody, inhibits HER2 signaling/dimerization, promotes receptor downregulation, and triggers antibody-dependent cellular cytotoxicity (ADCC) via FcγR+ NK cells. - Nab-paclitaxel: albumin-bound taxane, stabilizes microtubules, causing mitotic arrest. - Carboplatin: platinum chemotherapy, forms DNA crosslinks leading to apoptosis. Cells/pathways targeted: HER2-overexpressing breast tumor cells, ErbB/HER2 cascade, downstream PI3K/AKT/mTOR and MAPK pathways, immune effector NK cells (ADCC), microtubule dynamics in dividing cells, DNA replication/repair.