eligibility_summary
Eligibility: Adults ≥18, ECOG ≤2, HER2+ with prior anti-HER2 therapy, or HER2-low with prior systemic therapy for metastatic disease or relapse during/≤6 months after adjuvant, on goldtrastuzumab for advanced disease, able to comply and use effective contraception. Exclude: pregnant/lactating, serious infection/comorbidity, recent other cancers (with cured exceptions), psychiatric/poor compliance, major organ failure, trastuzumab allergy, non-PD/non-toxicity regimen change, otherwise unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Study type: Observational, real‑world use of DS‑8201 (trastuzumab deruxtecan, T‑DXd) in Chinese patients with metastatic HER2‑positive or HER2‑low breast cancer. Intervention/drug: DS‑8201 is a HER2‑targeted antibody‑drug conjugate (ADC). It consists of a humanized anti‑HER2 IgG1 (trastuzumab) linked via a cleavable linker to deruxtecan (DXd), a membrane‑permeable topoisomerase I inhibitor cytotoxic payload. Mechanisms of action: • Binds HER2 on tumor cells → internalization → lysosomal cleavage → DXd release → topoisomerase I inhibition → DNA damage and apoptosis. • Bystander effect from membrane‑permeable payload. • Trastuzumab component also inhibits HER2 signaling and can mediate ADCC via Fcγ receptors. Cells/pathways targeted: • HER2‑expressing breast cancer cells (HER2‑positive and HER2‑low). • HER2 signaling pathway, nuclear topoisomerase I, immune effector cells (e.g., NK cells) via ADCC.