eligibility_summary
Eligible: women 18–70 with HER2+ (IHC3+ or FISH+) invasive breast cancer, unresectable local recurrence or metastatic, measurable disease, ECOG 0–1, LVEF ≥50%, adequate organs, life expectancy ≥3 mo, negative pregnancy test/contraception, consent. Exclude: prior 1L anti‑HER2 for metastasis, adjuvant HER2 ≤12 mo or beyond trastuzumab/pertuzumab, progression on adjuvant trastuzumab, CNS mets, recent trials, systemic Tx in metastatic stage (except endocrine), allergy, pregnancy/lactation, major cardiac disease, investigator concern.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 4, single‑arm real‑world study in HER2+ recurrent/metastatic breast cancer. Interventions: 1) Inetetamab—humanized anti‑HER2 IgG1 monoclonal antibody (trastuzumab‑like). Mechanism: binds HER2 extracellular domain, inhibits HER2 signaling, and mediates Fc‑dependent ADCC. 2) Taxane chemotherapy (docetaxel, nab‑paclitaxel, or paclitaxel liposome)—cytotoxic microtubule stabilizers causing mitotic arrest and apoptosis. 3) ± Pertuzumab—humanized anti‑HER2 monoclonal antibody that binds HER2 dimerization domain, blocking HER2/HER3 pairing and enhancing ADCC. Targets/pathways: HER2 (ErbB2) on tumor cells, blockade of HER2 dimerization and downstream PI3K/AKT and MAPK signaling, engagement of immune effector (NK) cells via ADCC, proliferating cancer cells via microtubules.