eligibility_summary
Adults ≥18 with HR−, HER2‑low (IHC1+ or IHC2+/ISH−) invasive breast cancer, stage T1cN1‑2M0 or T2‑3N0‑2M0, treatment‑naive, surgery‑eligible, ECOG 0–1, measurable disease, adequate cardiac (NYHA<3, LVEF≥55%) and marrow/organ function, contraception and compliance required. Exclude bilateral/prior invasive BC, recent trials/surgery/live vaccines, prior IO/ADC, major CV/ILD/infections/autoimmunity, neuro/neuropathy, HBV/HCV/HIV/COVID, drug hypersensitivity, other recent malignancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II neoadjuvant trial in HR‑negative, HER2‑low breast cancer. Interventions: (1) Disitamab Vedotin (RC48-ADC), a HER2‑targeted antibody–drug conjugate carrying MMAE (microtubule inhibitor), (2) Toripalimab (JS001), an anti–PD‑1 monoclonal antibody (immune checkpoint inhibitor). Arms include DV+Toripalimab, DV+Toripalimab+Carboplatin, or DV+Toripalimab followed by epirubicin+cyclophosphamide+Toripalimab. Mechanisms/targets: DV binds HER2 on tumor cells (including low expressers), is internalized, and releases MMAE to disrupt microtubules and induce apoptosis, Toripalimab blocks PD‑1 on T cells to restore antitumor immunity, Carboplatin causes DNA crosslinks, Epirubicin inhibits topoisomerase II, Cyclophosphamide alkylates DNA. Targeted cells/pathways: HER2+ tumor cells, microtubule dynamics, DNA damage/repair, topo II, and PD‑1/PD‑L1 axis on T cells.