eligibility_summary
Adults (≥18) with unresectable/metastatic HER2+ breast cancer after ≥2 systemic lines, radiographic progression, ≥1 lesion, ECOG 0–1, adequate organs, life expectancy ≥12 wks, contraception required. Exclude: pregnant/breastfeeding, other cancers <3y, unresolved tox, malabsorption, recent therapy/surgery, max anthracyclines, active CNS mets, CV disease/LVEF<40, ILD, corneal disease, neuropathy ≥3, active infection, HBV/HCV/HIV, drug allergy, strong CYP3A use, other risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 randomized trial in HER2-positive advanced breast cancer comparing DP303c (3.0 mg/kg IV q3w) versus trastuzumab plus vinorelbine or capecitabine. Drugs and mechanisms: DP303c – investigational HER2-directed biologic (type/mechanism not specified in the registry, developed for HER2+ tumors). Trastuzumab – anti-HER2 monoclonal antibody that blocks ERBB2 signaling and mediates ADCC. Vinorelbine – vinca alkaloid microtubule inhibitor causing mitotic arrest. Capecitabine – oral prodrug of 5-FU inhibiting thymidylate synthase and DNA/RNA synthesis. Targets/pathways: HER2-overexpressing tumor cells, ERBB2–PI3K/AKT–MAPK signaling, microtubules, nucleotide synthesis/DNA replication.