eligibility_summary
Eligible: Adults ≥18 with new stage 2–3 HER2+ breast cancer (IHC3+/ISH+), no prior therapy, planned neoadjuvant, ECOG 0–1, LVEF ≥50%, adequate labs, agree to on‑treatment biopsy, negative pregnancy test and contraception. Exclude: metastatic disease, cardiac/QTc issues, uncontrolled HTN, recent thrombosis/stroke, active infection/bleeding/immunodef/hepatitis, ILD/major lung disease, live vaccine ≤30d, pregnancy/breastfeeding, hypersensitivity, unstable illness, recent other cancers (except cured).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm phase 2 neoadjuvant trial in early-stage HER2-positive breast cancer testing trastuzumab deruxtecan (T-DXd). T-DXd is an antibody–drug conjugate: a humanized anti-HER2 monoclonal antibody (trastuzumab) linked via a cleavable linker to a membrane-permeable topoisomerase I inhibitor payload (DXd). Mechanisms: (1) Binds HER2 (ERBB2) on tumor cells, attenuating HER2 signaling, (2) engages immune effector cells to trigger ADCC via Fcγ receptors, (3) after HER2-mediated internalization, releases DXd to inhibit topoisomerase I, causing replication-associated DNA damage and apoptosis, with a bystander effect. Targets: HER2-overexpressing breast cancer cells, HER2/PI3K–AKT/MAPK pathways, nuclear topoisomerase I in proliferating tumor cells, immune NK cell-mediated cytotoxic pathways. Post-op, pCR cases continue trastuzumab to complete ~1 year.