eligibility_summary
Eligibility: Adults 18–75 with HER2+ early breast cancer per ASCO/CAP, single/multifocal/multicentric per sampling rules, HR+ or HR–, clinical stage II–IIIC (AJCC 8), nodal involvement confirmed if applicable, ECOG 0–1. Exclude prior invasive breast cancer, stage IV, other malignancy within 3 yrs (except cured in situ or resected non-melanoma skin), DCIS unless mastectomy only, serious/uncontrolled disease or infections incl. IV anti-infectives.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Disitamab vedotin (RC48), an anti‑HER2 antibody–drug conjugate delivering the microtubule toxin MMAE, and pyrotinib, an oral, irreversible pan‑ErbB tyrosine‑kinase inhibitor (EGFR/HER1, HER2, HER4). Mechanisms: Disitamab vedotin binds HER2 on tumor cells, is internalized, and releases MMAE to disrupt microtubules and induce apoptosis, the antibody can also trigger ADCC. Pyrotinib covalently inhibits HER-family kinases, blocking downstream PI3K/AKT and MAPK signaling to curb proliferation and survival. Targets: HER2‑positive breast cancer cells, ErbB/HER signaling pathways, microtubules/cell cycle machinery.