eligibility_summary
Adults 16–90 with confirmed breast cancer (primary/relapsed/metastatic), life expectancy >3 mo, KPS≥60/ECOG 0–2, failed/no standard therapy, measurable disease, and biopsy/effusion for TILs. Adequate labs (counts, coagulation, renal, hepatic), fit for biopsy, contraception, ≥28‑day washout, consent. Exclude: high‑dose steroids/autoimmune, poor lung function, serious cardiac disease, HIV/HBV/HCV/syphilis or active infection, recent therapy, severe allergy to cell therapy, prior irAE>G3, unresolved AEs>G1, pregnant/lactating, prior transplant/dialysis, or other severe illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase I/II single-arm trial in advanced/metastatic refractory breast cancer testing: 1) Autologous tumor-infiltrating lymphocytes (TILs, adoptive T-cell therapy) expanded ex vivo, 2) Pembrolizumab (Keytruda, monoclonal antibody checkpoint inhibitor) targeting PD-1, 3) Aldesleukin/Interleukin-2 (cytokine therapy) to support T-cell proliferation, given after lymphodepletion with cyclophosphamide (alkylating chemotherapy) and fludarabine (purine analog) to enhance TIL engraftment. Mechanisms/targets: TILs deliver tumor-specific cytotoxic CD8+/CD4+ T cells, pembrolizumab blocks PD-1 to reverse T-cell exhaustion, IL-2 activates IL-2R (JAK/STAT) to expand/activate T cells, lymphodepletion reduces endogenous lymphocytes/Tregs/MDSCs and boosts homeostatic cytokines. Key pathways: PD-1/PD-L1 axis, IL-2 signaling, tumor antigen–specific T-cell cytotoxicity.