eligibility_summary
Eligible: 18–75, ECOG 0–1, life ≥3 mo, HER2+ recurrent/metastatic breast cancer not curable by surgery/RT, prior progression/intolerance, ≥1 measurable lesion, adequate organ function, contraception required (WOCBP: negative test, no lactation). Exclude: recent other cancer, unresolved AEs ≥G2, recent major surgery/trauma, unhealed wounds, ILD/pneumonitis, thrombosis <6 mo, severe/uncontrolled disease, recent anti-tumor therapy (incl. Chinese patent drugs), vessel invasion/bleeding risk, uncontrolled effusions, CNS/meningeal mets, severe bone injury, allergy to study drug/mAbs, recent trial, or investigator-judged risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: TQB2102 for injection, a HER2-targeted antibody–drug conjugate (biologic) composed of a humanized anti‑HER2 monoclonal antibody, an enzyme‑cleavable linker, and a topoisomerase I inhibitor payload. Mechanism of action: The antibody binds HER2 on tumor cells and is internalized, intracellular linker cleavage releases the topo I inhibitor, which blocks topoisomerase I–mediated DNA replication, causing DNA damage and cell death, while leveraging antibody targeting to limit systemic exposure. Targets: HER2-expressing breast cancer cells, HER2 receptor tyrosine kinase, DNA replication machinery (topoisomerase I).