eligibility_summary
Eligible: ≥18 with HER2+ (IHC/ISH) invasive breast cancer, stage T2–3, cN0–3, M0, planned surgery, no prior systemic therapy, measurable disease, adequate cardiac and organ function, contraception and compliance required. Exclude: bilateral/prior invasive BC, prior PD‑(L)1/CTLA4/anti‑HER2, recent investigational drug/surgery/live vaccine, transplant, major CV, ILD/lung, neuro/psychiatric or ≥G2 neuropathy, active infections (HIV, HBV/HCV, COVID‑19), active autoimmune, recent other cancers, drug hypersensitivity, other serious illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II neoadjuvant study in HER2-positive breast cancer testing: 1) Disitamab vedotin (DV/RC48), an anti-HER2 antibody-drug conjugate that binds HER2 on tumor cells, is internalized, and releases the microtubule inhibitor MMAE to induce cell-cycle arrest/apoptosis, may also trigger ADCC. 2) Pertuzumab, an anti-HER2 IgG1 monoclonal antibody that blocks HER2 dimerization (subdomain II), inhibiting downstream PI3K/AKT and MAPK signaling and mediating ADCC. 3) Toripalimab (JS001), a PD-1–blocking IgG4 monoclonal antibody (immune checkpoint inhibitor) that restores T-cell activity. Arms: DV + pertuzumab ± toripalimab. Targets: HER2-overexpressing tumor cells, HER2 dimerization/signaling, microtubules, PD-1 on T cells, NK-cell Fc-mediated cytotoxicity.