eligibility_summary
Eligible: women ≥18 with untreated, nonmetastatic, biopsy-amenable T2+ TNBC (ER/PgR−, HER2−), ECOG 0–1, negative pregnancy test if WOCBP, adequate hepatic/renal/marrow function. Exclude: prior systemic TNBC therapy, prohibited meds/live vaccine, aspirin/NSAID use or intolerance, metastases, major CVD, serious illness, HIV+ or active HBV/HCV, active autoimmune disease/immunosuppression, ILD, GI issues, pregnant/breastfeeding, active infection, drug hypersensitivity, recent other cancer.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT04188119 tests: 1) Avelumab (Bavencio) — a human IgG1 monoclonal antibody immune checkpoint inhibitor that blocks PD-L1 from binding PD-1/CD80, restoring cytotoxic T‑cell activity and potentially engaging NK cell ADCC, 2) Aspirin — an NSAID that irreversibly inhibits COX‑1/COX‑2, lowering prostaglandin (notably PGE2) to reduce tumor-promoting inflammation and immunosuppression, 3) Lansoprazole — a proton pump inhibitor given for GI protection (not antitumor). Targeted cells/pathways: PD-1/PD-L1 axis on tumor/immune cells to reactivate CD8+ T cells, NK cells via avelumab’s Fc, COX–prostaglandin pathway to modulate the tumor microenvironment, aiming to decrease suppressive myeloid cells (e.g., TAMs/MDSCs) and enhance dendritic cell function and TIL infiltration in triple‑negative breast cancer.