eligibility_summary
Eligibility: Adults 18–75, ECOG 0–1, unresectable/metastatic breast cancer with low HER2 (IHC 1+ or 2+/ISH– or 0<IHC<1+), HR any, progressed on endocrine therapy, ≥1 prior chemo in recurrent/metastatic, measurable disease (RECIST 1.1), adequate organ/coagulation, contraception. Exclude: prior anti‑angiogenic TKIs, prior exatecan topoisomerase‑I ADC, ILD/pneumonitis, unresolved toxicities, major CVD, bleeding, unhealed wounds/ulcers/fractures, recent VTE/ATE, active CNS metastases/spinal compression, other unsafe conditions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase Ib (dose escalation) trial testing: 1) Anlotinib—an oral small‑molecule multikinase TKI that inhibits VEGFR1‑3, FGFR1‑4, PDGFRα/β, and c‑KIT, primary action: anti‑angiogenesis, reducing endothelial proliferation and tumor vasculature. 2) Trastuzumab deruxtecan (DS‑8201)—a HER2‑targeted antibody‑drug conjugate: anti‑HER2 monoclonal antibody plus a cleavable linker to a topoisomerase I inhibitor (deruxtecan), binds HER2 on tumor cells, is internalized, then releases cytotoxic payload (with bystander killing). Targets/pathways: HER2‑low breast cancer cells, DNA replication via topoisomerase I, tumor angiogenesis pathways mediated by VEGF, FGF, and PDGF signaling in endothelial/perivascular cells.