eligibility_summary
Adults ≥18 with locally advanced/metastatic breast cancer progressed after ≥2nd‑line therapy, HR‑negative, HER2‑low (IHC1+ or 2+/ISH−), ECOG 0–1, life expectancy >12 wks, adequate organ function, LVEF≥50%, measurable disease, contraception, consent. Exclude: 2nd‑line paclitaxel within 3 mo, other recent malignancy, major surgery <4 wks, prior ADC/anti‑angiogenic/anti‑HER2, serious CV disease, drug allergy, immunodeficiency/HIV/transplant, active/recent brain mets, pregnancy, or other conditions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II single-arm trial in HR‑negative, HER2‑low metastatic breast cancer testing: 1) Disitamab vedotin (RC48), a HER2‑targeted antibody–drug conjugate that binds HER2 on tumor cells, is internalized, and releases the microtubule inhibitor MMAE via a cleavable linker to disrupt mitosis and induce apoptosis, 2) Anlotinib, an oral multi‑target anti‑angiogenic tyrosine kinase inhibitor of VEGFR2/3, FGFR1‑4, PDGFRα/β, c‑Kit, and RET. Targets/pathways: HER2 on HER2‑low tumor cells, microtubules (MMAE cytotoxicity), and tumor vasculature via VEGF/FGF/PDGF signaling in endothelial/perivascular cells to inhibit angiogenesis.