eligibility_summary
Eligible: women 18–70 with core‑biopsy–proven invasive breast cancer, HER2‑negative, primary ≥1 cm, N0–3, M0, after 2 cycles doxorubicin/epirubicin+cyclophosphamide with MRI‑stable disease, no other prior therapy, accessible tumor‑draining nodes, ECOG 0–1, adequate organ function (LVEF ≥50%, FEV1 ≥60%), contraception, AEs ≤Grade 1. Exclude: metastatic/recent cancers, major cardiac/pulmonary disease, infection/TB/HBV/HCV (unless controlled), HIV/autoimmunity, pregnancy, thrombosis/live vaccine, transplant, prohibited drugs/allergies, IL‑2 contraindications, ≥Grade 2 neuropathy, other risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Open-label Phase I/II neoadjuvant study in HER2-negative breast cancer. Interventions: 1) Autologous tumor-draining lymph node–derived lymphocytes (LNLs, adoptive T-cell therapy) given after lymphodepleting cyclophosphamide (alkylating agent, DNA crosslinking) + fludarabine (purine analog, inhibits DNA synthesis) and supported by interleukin-2 (cytokine, IL‑2R signaling to expand/activate T cells). LNLs are ex vivo expanded, tumor‑reactive, minimally exhausted T cells harvested via sentinel lymph node biopsy. 2) Background chemotherapy: doxorubicin or epirubicin (anthracyclines, DNA intercalation/topoisomerase II inhibition/ROS) + cyclophosphamide, then nab‑paclitaxel (taxane, microtubule stabilization). Targets/pathways: tumor‑specific CD8+/CD4+ T cells, IL‑2/IL‑2R signaling, lymphodepletion reduces regulatory/competing lymphocytes, cytotoxic chemo drives tumor cell death (DNA damage, mitotic arrest) to enhance antigen release.