eligibility_summary
Women 18–70 with HER2+ (IHC 3+ or 2+/FISH+) stage IV breast cancer, no systemic therapy for recurrence/metastasis, ≥1 measurable lesion (RECIST 1.1), ECOG 0–1, and adequate marrow, liver, renal, thyroid, albumin. Exclude prior HER2 TKI, active/untreated CNS or leptomeningeal disease, other malignancy <5y, antitumor therapy <4w, pregnancy/lactation, GI malabsorption, symptomatic effusions, immunodeficiency/HIV/transplant, major surgery/trauma <4w, serious comorbidities, noncompliance, per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, open-label, first-line HER2+ metastatic breast cancer trial in China comparing pyrotinib dose escalation (240→320→400 mg QD) vs immediate 400 mg QD, each with trastuzumab (q3w) and docetaxel (q3w). Interventions and mechanisms: Pyrotinib—oral small-molecule, irreversible pan-ErbB tyrosine kinase inhibitor (EGFR/HER1, HER2, HER4) that blocks receptor phosphorylation and downstream PI3K-AKT and MAPK signaling to inhibit proliferation, Trastuzumab—humanized anti-HER2 IgG1 monoclonal antibody that blocks HER2 signaling/dimerization and mediates ADCC via Fcγ receptor–bearing immune cells, Docetaxel—taxane cytotoxic that stabilizes microtubules causing mitotic arrest/apoptosis. Targets/pathways: HER2-overexpressing tumor cells, ErbB/HER2 axis, PI3K/AKT/mTOR and RAS/RAF/MEK/ERK pathways, microtubules in dividing cells, immune effector ADCC. Primary endpoint: grade ≥3 diarrhea early cycles.