eligibility_summary
Eligibility: Women 18–75 with metastatic HER2+ breast cancer (IHC 3+ or 2+/FISH+), no prior metastatic chemo, measurable disease (RECIST 1.1), ECOG ≤2, ≥3‑mo expectancy, prior AEs ≤G1, adequate marrow/organ function, LVEF ≥55%, QTcF ≤470 ms, known hormone status, negative pregnancy test and effective non‑hormonal contraception, consent. Exclude: HER2−, drug allergy, pregnant/lactating or no contraception, serious/uncontrolled disease (e.g., cardiac, HTN, infection, active HBV) or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III NCT06278870 tests disitamab vedotin (RC‑48) + pyrotinib vs standard THP (taxane + trastuzumab + pertuzumab) as first‑line therapy for HER2+ metastatic breast cancer, maintenance: trastuzumab+pyrotinib (exp) vs trastuzumab+pertuzumab (ctl). Disitamab vedotin is an anti‑HER2 antibody‑drug conjugate delivering MMAE, a microtubule‑disrupting cytotoxin, after HER2‑mediated internalization, its IgG1 can trigger ADCC. Pyrotinib is an oral, irreversible pan‑HER (EGFR/HER2/HER4) TKI that inhibits PI3K/AKT and MAPK pathways. Trastuzumab and pertuzumab are anti‑HER2 monoclonal antibodies, trastuzumab inhibits HER2 signaling/mediates ADCC, pertuzumab blocks HER2/HER3 dimerization. Taxanes are microtubule‑stabilizing cytotoxics. Targets: HER2‑overexpressing tumor cells, ErbB signaling, microtubules, immune ADCC pathways.