eligibility_summary
Eligibility: Female 18–75, HER2+ invasive breast cancer, pre-NAT cT1–4 N0–3 M0 (not T1N0), residual invasive disease post-surgery per stage-specific rules, ≥6 cycles NACT incl ≥9 wks taxane and ≥9 wks trastuzumab, radical surgery, start 3–12 wks after, HR status known, ECOG 0–1, adequate cardiac, contraception. Exclude stage IV/recurrence, other malignancy ≤5y (except cured BCC/cervical in situ), prior HER2-ADC, excess anthracyclines, major CV disease/MI<6mo, ILD, bleeding/thrombosis risk, active HBV/HCV/cirrhosis, other serious risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drugs/interventions and mechanisms: • SHR-A1811: a HER2-targeted antibody–drug conjugate (ADC). The anti-HER2 monoclonal antibody binds ERBB2 (HER2) on tumor cells, is internalized, and releases a cytotoxic payload (type not specified in the record), while retaining trastuzumab-like HER2 signaling inhibition and Fc-mediated antibody-dependent cellular cytotoxicity (ADCC). • Ado-trastuzumab emtansine (T-DM1): a HER2-ADC linking trastuzumab to DM1 (maytansinoid microtubule inhibitor) via a non-cleavable linker, it blocks HER2 signaling, mediates ADCC, and delivers DM1 to disrupt microtubules, causing mitotic arrest and apoptosis. Cells/pathways targeted: • HER2/ERBB2-overexpressing breast cancer cells. • HER2-driven signaling cascades (PI3K/AKT and MAPK/ERK). • Microtubules (via DM1 in T-DM1 arm). • Immune effector engagement via Fcγ receptors (ADCC by NK cells/macrophages).