eligibility_summary
Eligible: adults with HER2+ invasive breast cancer, ECOG 0–1, life expectancy >3 mo, no prior systemic therapy, stage T0–4 N1–3 M0 or T2–4 N0 M0, adequate organ function, willing for surgery after neoadjuvant, contraception and negative pregnancy test (non‑lactating). Exclude: stage IV/unresectable, bilateral disease, recent other cancers/surgery/therapy, major comorbidities (cardiac, thromboembolism, ILD, infection), allergy/autoimmunity, other trials, or investigator concern.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 randomized, open-label neoadjuvant study in HER2-positive breast cancer testing TQB2102 for injection, a HER2-targeted dual‑antibody–drug conjugate (ADC). Dosing: IV every 3 weeks for 6–8 cycles at 6.0 or 7.5 mg/kg. Mechanism: the antibody component binds HER2 on tumor cells, is internalized, and releases an intracellular cytotoxic payload to kill HER2-expressing cells, it may also dampen HER2 signaling and engage Fc-mediated immune effector functions. Targets: HER2/ErbB2-overexpressing breast cancer cells and the HER2 signaling axis (downstream PI3K/AKT and MAPK pathways). No other agents are used.