eligibility_summary
Include: women 18–70, HER2‑negative invasive breast cancer by core biopsy, tumor ≥1 cm, N0–3/M0, SD after AC×2, no other prior therapy or SLNB/ALND, accessible draining nodes, ECOG 0–1, adequate organ function, contraception, AEs ≤G1. Exclude: metastasis, recent other cancer, major cardiac/respiratory disease, active infection/fever or recent thrombosis, autoimmune or immunodeficiency, TB, active HBV/HCV, severe drug allergy/IL‑2 contraindication, neuropathy ≥2, pregnancy/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Interventions: neoadjuvant adoptive cell therapy using autologous tumor-draining lymph node–derived lymphocytes (LNL, cellular immunotherapy) after lymphodepleting chemotherapy (cyclophosphamide + fludarabine), with IL-2 support, integrated with standard neoadjuvant chemotherapy (doxorubicin or epirubicin + cyclophosphamide, then nab-paclitaxel). Mechanisms: LNL supply expanded tumor-reactive T cells mediating TCR-dependent cytotoxicity, IL-2 (immunostimulatory cytokine) promotes T-cell proliferation/survival via IL-2R/JAK-STAT, lymphodepletion reduces endogenous lymphocytes (incl. Tregs) and creates a homeostatic niche for engraftment. Chemo mechanisms: doxorubicin/epirubicin (anthracycline topoisomerase II inhibitors), cyclophosphamide (alkylating DNA crosslinker), fludarabine (purine analog antimetabolite), nab-paclitaxel (microtubule stabilizer). Targets: tumor-reactive CD8+/CD4+ T cells, tumor cells, and immunosuppressive lymphocytes.