eligibility_summary
Adults ≥18 with stage II–III TNBC eligible for neoadjuvant anti‑PD‑1 + anthracycline/taxane, biopsyable tumor (≥30% cells), adequate marrow/liver/renal, ECOG ≤2, able for MRI/US, consent. Exclude: major comorbidity or unresolved severe toxicity, recent other cancer, prior transplant, immunodeficiency/autoimmune, active infection (HIV/HBV/HCV), major GI disease/surgery, bleeding/anesthesia risk, pregnancy, contraception, live vaccine ≤30 d, other trials/therapy, nonadherence or substance abuse.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: NECVAX-NEO1, a personalized, bacteria-based oral DNA vaccine encoding patient-specific tumor neoantigen epitopes, pembrolizumab (anti-PD-1 monoclonal antibody, checkpoint inhibitor), epirubicin (anthracycline, topoisomerase II inhibitor), cyclophosphamide (alkylating agent), and nab-paclitaxel (taxane, microtubule stabilizer). Mechanisms: NECVAX-NEO1 delivers plasmid DNA to gut-associated antigen-presenting cells, enabling in vivo expression of neoantigens and presentation via MHC I/II, priming and boosting neoantigen-specific CD8+ cytotoxic and CD4+ helper T-cell responses against TNBC cells. Pembrolizumab blocks the PD-1/PD-L1 pathway to reverse T-cell exhaustion and enhance effector function. Chemotherapy kills proliferating tumor cells, can induce immunogenic cell death, increase antigen release, and modulate the tumor microenvironment. Cells/pathways targeted: dendritic cells/APCs, CD8+/CD4+ T cells, TCR-MHC antigen presentation, PD-1 checkpoint, DNA replication/repair, and mitotic spindle.