eligibility_summary
Eligible: females ≥18 with untreated, operable HER2+ (IHC3+/ISH+) breast cancer, stage cT2 (>2–5 cm), cN0, M0, ECOG 0–1, LVEF ≥50%, adequate marrow/organ function, protocol washouts, negative pregnancy/postmenopause, non‑hormonal contraception, consent. Exclude: inflammatory/unresectable, prior invasive breast ca, recent other cancers, metastasis, prior cytotoxics, investigational drugs, major comorbidity/noncompliance, cardiac/QT/arrhythmia, ILD/pulmonary disease, active HIV/HBV/HCV/infection, live vaccine ≤30d, unresolved >G1 tox (allowed stable G2), hypersensitivity, pregnancy/breastfeeding, hormonal contraception/HRT.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06548178 (EXTEND), phase 2 neoadjuvant, HER2+ cT2N0M0 early breast cancer. Interventions and mechanisms: • T-DXd (trastuzumab deruxtecan): HER2-directed antibody–drug conjugate. Trastuzumab targets HER2 on tumor cells, internalizes, cleavable linker releases deruxtecan (topoisomerase I inhibitor) causing DNA damage/apoptosis. Retains trastuzumab functions (HER2 signaling blockade, ADCC) and has a bystander effect. • THP standard: Docetaxel (taxane cytotoxic, stabilizes microtubules → mitotic arrest), Trastuzumab (anti-HER2 monoclonal antibody, inhibits HER2 signaling, mediates ADCC), Pertuzumab (anti-HER2 monoclonal antibody, blocks HER2/HER3 dimerization). Targets/pathways: HER2-overexpressing breast cancer cells, HER2 receptor tyrosine kinase, downstream PI3K/AKT and MAPK signaling, topoisomerase I, microtubule dynamics, immune effector ADCC via NK cells.