Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer

Phase I: Incidence of Dose-Limiting Toxicity (DLT),Phase I: Incidence of Grade≥3 Treatment-Emergent Adverse Event (TEAE),Phase II: Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 at the time of definitive surgery

RATIONALE: Patients with HER2-negative breast cancer not responding to initial neoadjuvant
 chemotherapy might have lower chances for a pathologic complete response (pCR) at definitive
 surgery, indicating worse prognosis. Adoptive cell therapy has demonstrated efficacy in
 advanced breast cancer, but whether the addition of adoptive cell therapy to neoadjuvant
 chemotherapy could increase the pCR rate remains unclear. Tumor-draining lymph node-derived
 lymphocytes (LNLs) that have abundant tumor-reactive T cells, but not exhausted T cells, are
 easy to produce. It is not yet known whether LNL treatment is safe and effective in patients
 with HER2-negative breast cancer not responding to neoadjuvant chemotherapy.
 
 PURPOSE: This open-label phase I/II trial is to investigate the safety and efficacy of
 autologous LNL in patients with HER2-negative breast cancer not responding to neoadjuvant
 chemotherapy.