eligibility_summary
Eligible: women ≥18 with ECOG 0–1, life expectancy ≥12 wks, unresectable/advanced or metastatic breast cancer with ≥1 RECIST 1.1 measurable lesion, HER2-low (IHC1+ or IHC2+/FISH–) or ultralow, adequate organ function, no prior ADC, ≤1 prior chemo for advanced disease, HR status available (HR+ ≤2 prior endocrine lines). Exclude: thromboembolism history, uncontrolled systemic disease, active infections, pregnant/lactating, brain mets or leptomeningeal disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Disitamab vedotin (RC48-ADC), an antibody-drug conjugate (targeted cytotoxic/immunotherapy). Mechanism: a humanized anti-HER2 monoclonal antibody (disitamab) linked via a cleavable linker to the microtubule-disrupting payload MMAE. After binding HER2 on tumor cells (including HER2-low/ultralow), the ADC is internalized, lysosomal cleavage releases MMAE, inhibiting tubulin polymerization, leading to G2/M arrest and apoptosis. Additional effects may include Fc-mediated ADCC and a bystander effect from membrane-permeable MMAE. Targets: HER2-expressing breast cancer cells, pathways impacted include HER2 receptor signaling at the tumor surface and microtubule/cell-cycle machinery.