eligibility_summary
Adults ≥18 with unresectable locally advanced/metastatic HER2+ breast cancer, previously treated with trastuzumab+taxane, ECOG 0–2, adequate organs, life ≥3 months, contraception. Exclude: prior tubulin‑inhibitor HER2 ADC, other cancer ≤3y, uncontrolled effusions, contraindications, unresolved AEs >G1 or ≥G2 peripheral nephropathy, recent therapy/major surgery, unstable CNS mets, maxed anthracycline, LVEF<40%/serious CV disease, ILD, ocular disease/contacts, serious infection, other risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06313086: Phase 3, randomized, open-label trial in HER2-positive advanced breast cancer comparing DP303c (3.0 mg/kg IV Q3W) vs trastuzumab emtansine/T-DM1 (3.6 mg/kg IV Q3W). Drugs and mechanisms (type): • DP303c—HER2-targeted antibody–drug conjugate (ADC). Binds HER2, is internalized, and releases an intracellular cytotoxic payload to kill tumor cells, anti-HER2 antibody component can also inhibit HER2 signaling and mediate ADCC. • Trastuzumab emtansine (T-DM1)—HER2-targeted ADC linking trastuzumab to DM1 (maytansinoid microtubule inhibitor). After HER2 binding and internalization, DM1 disrupts microtubules, trastuzumab functions (HER2 blockade, ADCC) are retained. Targets: HER2/ERBB2-overexpressing breast cancer cells, HER2 signaling pathways (PI3K/AKT/MAPK), microtubule dynamics (T-DM1), and Fc-mediated ADCC.