eligibility_summary
Inclusion: Women 18–75, confirmed HER2+ invasive BC (early T1c–3 N0–1 M0 or locally advanced T2–4 N2/3 M0), ECOG 0–1, planned definitive surgery, adequate organ function (ANC≥1.5, PLT≥90, Hb≥90, LFTs/renal OK, LVEF≥55%, QTcF<470), contraception if needed, consent. Exclusion: drug allergy, other malignancy, recent trial <4 wks, stage IV, oral med issues, CHF/major heart disease, infection/severe psych illness, pregnant/lactating, immunodef/HIV/transplant, other serious conditions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06035679 tests dual HER2 blockade plus chemotherapy as neoadjuvant therapy for HER2-positive early/locally advanced breast cancer. Drugs/interventions: 1) Pyrotinib (small‑molecule, irreversible pan‑ERBB tyrosine kinase inhibitor of HER1/EGFR, HER2, HER4) that suppresses downstream PI3K/AKT and MAPK signaling. 2) Trastuzumab (monoclonal IgG1 antibody) that binds HER2’s extracellular domain, blocks receptor activation/dimerization, and induces antibody‑dependent cellular cytotoxicity (ADCC). 3) Taxoids (docetaxel/paclitaxel, cytotoxic microtubule stabilizers) causing mitotic arrest. 4) Carboplatin (platinum DNA cross‑linker) causing DNA damage. Targets: HER2‑overexpressing breast cancer cells, ERBB receptor signaling pathways (PI3K/AKT, MAPK), immune effector mechanisms via NK cell–mediated ADCC, cytoskeletal microtubules, and tumor cell DNA replication/repair. Primary endpoint: total pathologic complete response.