eligibility_summary
Include: Women 18–70, newly treated, ECOG 0–1, life ≥3 mo, RECIST‑measurable HER2‑low stage II–III, adequate organ function (incl. CrCl≥50, LVEF≥50, QTcF<470), tissue for biomarkers, negative pregnancy and contraception, consent. Exclude: inflammatory or stage IV, recent therapy/trial/live vaccine, prior HER2‑targeted/ADC/IO, other cancer <5 y, concurrent therapy, uncontrolled effusions, active autoimmune/immunosuppression, TB/HIV/HBV/HCV, major cardiac/neuro/psych disease, pregnant/lactating.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests two agents as neoadjuvant therapy in HER2‑low early/locally advanced breast cancer: 1) Disitamab vedotin (RC48) – an antibody‑drug conjugate (ADC) targeting HER2. The anti‑HER2 antibody binds HER2 on tumor cells, is internalized, and releases the cytotoxic payload MMAE, disrupting microtubules to induce apoptosis and possible bystander killing. Drug type: ADC with microtubule inhibitor payload. Targets/pathways: HER2 receptor on breast cancer cells, microtubules/cell cycle. 2) Penpulimab (AK105) – a humanized anti‑PD‑1 monoclonal antibody (immune checkpoint inhibitor) that blocks PD‑1/PD‑L1 signaling to restore T‑cell activation and antitumor cytotoxicity. Drug type: IgG anti‑PD‑1 mAb. Targets/pathways: PD‑1 on T lymphocytes, T‑cell activation in the tumor microenvironment. Single‑arm q3w×6 neoadjuvant study assessing DCR/ORR pre‑op and pCR at surgery.