eligibility_summary
Eligibility: Adults 18–75 with unresectable HER2+ recurrent/metastatic breast cancer, no prior systemic therapy for advanced disease, ≥1 measurable lesion (RECIST 1.1), ECOG 0–1, normal organ function, consent/compliant. Exclude: prior systemic therapy at recurrence/metastasis or any HER‑targeted TKI, unsuitable for chemo, active brain metastases, recent/planned major surgery/trauma, serious cardiac disease, GI issues impairing oral drug use.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06362096: Phase 2, single-arm, first-line HER2+ advanced breast cancer study of trastuzumab + pyrotinib + a taxane, with prophylactic/PRN montmorillonite to reduce pyrotinib-induced diarrhea. Mechanisms/types: • Trastuzumab: humanized anti-HER2 IgG1 monoclonal antibody, binds HER2 on tumor cells, inhibits HER2 signaling and triggers ADCC via immune effector cells (e.g., NK cells). • Pyrotinib: oral, irreversible pan-ERBB tyrosine kinase inhibitor, blocks HER2/EGFR/HER4, suppressing downstream PI3K–AKT and MAPK pathways. • Taxane (paclitaxel/docetaxel class): cytotoxic microtubule stabilizer causing mitotic arrest/apoptosis in dividing tumor cells. • Montmorillonite: adsorbent antidiarrheal that protects intestinal mucosa by binding fluids/irritants. Targets: HER2-overexpressing breast cancer cells, ERBB signaling axis, immune ADCC pathway, microtubules, gut epithelium for toxicity mitigation.