eligibility_summary
Eligible: women 18–70 with HER2+ invasive breast cancer (IHC 3+ or ISH amp), recurrent/metastatic, relapse ≥3 mo after stopping trastuzumab, ≥1 measurable lesion (RECIST 1.1), ECOG 0–2, life expectancy ≥3 mo, normal organ function, consent. Exclude: severe drug allergy, prior systemic Rx for advanced disease, serious cardiac/pulmonary/hepatic disease (HBV DNA <1e3 IU/mL if HBV+), active infection, other invasive cancers, recent major surgery, or investigator deems unfit
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
This single-arm trial tests: 1) Pyrotinib (oral irreversible pan‑HER tyrosine kinase inhibitor) that blocks EGFR/HER2/HER4 signaling, suppressing downstream PI3K/AKT and MAPK pathways, 2) Trastuzumab (IV humanized anti‑HER2 monoclonal antibody) that inhibits HER2 signaling/dimerization and mediates immune ADCC, 3) Taxanes (cytotoxic microtubule‑stabilizing chemotherapies, e.g., paclitaxel/docetaxel) causing mitotic arrest, then, when taxanes stop, 4) Capecitabine (oral prodrug of 5‑FU antimetabolite) inhibiting thymidylate synthase and DNA/RNA synthesis. Targets: HER2‑overexpressing breast cancer cells, ErbB receptor axis (HER2/EGFR/HER4), PI3K/AKT and RAS/RAF/MEK/ERK pathways, microtubules in dividing cells, NK cell–mediated ADCC, thymidylate synthase–dependent DNA synthesis.