eligibility_summary
Inclusion: women 18–70, ECOG 0–1, HR+/HER2+ breast cancer cT1–4/N1–3/M0, ≥4 cycles neoadjuvant H+P, RCB 0–I, surgery≤12 wks, adequate labs, LVEF≥50%, life≥6 mo, contraception, consent. Exclude: recurrence, stage IV or bilateral, recent other malignancy, prior TKIs/T-DM1/immunotx, concurrent trials, major cardiac disease, GI malabsorption, neuropsych disorders, allergy/immunodeficiency/transplant, pregnancy/lactation, active HBV/HCV/TB/syphilis or severe illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase III, randomized, open-label adjuvant study in HR+/HER2+ early breast cancer with RCB 0/I after neoadjuvant trastuzumab+pertuzumab. Interventions: 1) Trastuzumab + neratinib vs 2) Trastuzumab + pertuzumab. Drug types and mechanisms: • Trastuzumab—monoclonal IgG1 anti-HER2 antibody binding the extracellular domain, inhibits HER2 signaling and promotes antibody-dependent cellular cytotoxicity. • Pertuzumab—monoclonal anti-HER2 antibody binding domain II, blocks HER2 dimerization (especially HER2–HER3), reducing downstream signaling. • Neratinib—irreversible, small-molecule pan-HER tyrosine kinase inhibitor that covalently inhibits EGFR/HER1, HER2, and HER4 kinase activity. Cells/pathways targeted: HER2-overexpressing breast cancer cells, ERBB/HER signaling network, including HER2–HER3 heterodimers, downstream PI3K–AKT–mTOR and RAS–RAF–MEK–ERK pathways, immune effector–mediated ADCC via trastuzumab.