eligibility_summary
Adults ≥18 with stage III IBC ≤6 mo, HER2+ or HER2‑low, treatment‑naïve, ECOG 0–1, LVEF ≥50%, adequate organ function, >30 kg, agree to baseline+C1D8 tumor biopsies/archival, contraception. Exclude prior IBC therapy/surgery/radiation, drug hypersensitivity, uncontrolled illness, immunosuppression/autoimmune, ILD/pulmonary disease, QTc>470 or recent cardiac events, active malignancy, VTE ≤3 mo, TB/HBV/HCV/HIV, live vaccine ≤30 d, strong CYP3A/2C9/2D6 meds or recent HCQ, pregnancy/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 neoadjuvant trial in stage III inflammatory breast cancer (HER2-positive or HER2-low) testing trastuzumab deruxtecan (T-DXd, antibody–drug conjugate) plus durvalumab (anti–PD-L1 monoclonal antibody, immune checkpoint inhibitor). T-DXd: a HER2-targeted IgG1 linked to a topoisomerase I inhibitor (deruxtecan), it binds HER2 (including low expressers), is internalized, releases payload to inhibit Topo I, causing DNA damage/apoptosis, with a membrane-permeable bystander effect, the antibody can also mediate ADCC. Durvalumab blocks PD-L1 from engaging PD-1/CD80, restoring T-cell activation and antitumor immunity. Targets/pathways: HER2 on tumor cells, Topo I–dependent DNA replication, Fc-mediated NK-cell ADCC, and the PD-1/PD-L1 axis on tumor and immune cells. Two parallel cohorts receive 8 cycles before surgery.