eligibility_summary
Include: Female 18–75, ECOG 0–1, untreated stage II–III invasive breast cancer with ≥1 lesion >2 cm, HR‑negative/low and HER2‑low, adequate organ function, effective contraception, not pregnant/breastfeeding, consented. Exclude: bilateral, stage IV or inflammatory BC, recent DCIS/LCIS, prior invasive BC or systemic therapy/radiation/surgery, major lung/cardiac/QT disease, HIV/TB/HBV/HCV, recent thrombosis, infection, bleeding/coag issues or anticoag, recent immuno‑stimulant/suppressant, live vaccine <30 d, other trials, transplant, postpartum ≤1 y, substance abuse, other serious illness or allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06592625 is a single-arm, phase 2 neoadjuvant study in HR‑negative/low, HER2‑low early or locally advanced breast cancer testing: 1) SHR-A1811: a HER2-targeted antibody–drug conjugate (ADC). Mechanism: binds HER2 on tumor cells, undergoes receptor-mediated internalization, and releases a cytotoxic payload inside the cell to induce tumor cell death, with potential bystander and immunogenic effects. 2) Adebrelimab: an anti–PD-L1 monoclonal antibody (immune checkpoint inhibitor) that blocks PD-L1 from engaging PD-1/CD80, restoring T‑cell antitumor activity. Targeted cells/pathways: HER2-expressing (including HER2‑low) breast cancer cells via HER2 receptor–mediated delivery and downstream cell‑death pathways, the PD‑1/PD‑L1 immune checkpoint on T cells and tumor/immune cells within the tumor microenvironment.