eligibility_summary
Adults 18–75 with inoperable locally advanced or recurrent/metastatic HER2+ breast cancer (IHC 3+ or FISH+), ≥1 measurable lesion, ECOG 0–1, no prior systemic therapy for advanced disease (except 1L endocrine), adequate organ/cardiac function. Exclude: unfit for chemo, severe neuropathy, recent major surgery/trauma, significant cardiac disease or uncontrolled HTN, immunodeficiency (incl. HIV/transplant), uncontrolled effusions, pregnancy/lactation or no contraception, serious infection/active HBV.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Prospective, multicenter real-world observational study of inetetamab-based first-line therapy in HER2-positive inoperable locally advanced or recurrent/metastatic breast cancer. Regimens: inetetamab + chemotherapy, inetetamab + pyrotinib + chemotherapy, inetetamab + pertuzumab + chemotherapy. Drugs and mechanisms: • Inetetamab: humanized anti-HER2 monoclonal antibody (trastuzumab-like), binds HER2 extracellular domain, inhibits HER2 signaling and induces ADCC. • Pertuzumab: anti-HER2 monoclonal antibody, blocks HER2 dimerization (especially HER2/HER3). • Pyrotinib: irreversible pan-ErbB small-molecule TKI targeting HER2/EGFR/HER4. • Chemotherapy: cytotoxic agents. Cells/pathways targeted: HER2-overexpressing tumor cells, ErbB/HER2 receptor activation and dimerization, downstream PI3K/AKT and MAPK signaling, immune effector–mediated ADCC (NK cells/macrophages).