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

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 treat

Trial Details

NCT ID
NCT05981014
Phase
PHASE1 / PHASE2
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Sentinel Lymph Node Biopsy (SLNB)
  • Doxorubicin
  • Epirubicin
  • Cyclophosphamide
  • Fludarabine
  • Tumor-draining lymph node-derived lymphocyte (LNL)
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • In order to be eligible for participation in this trial, the participant must:
  • Have signed the informed consent to study participation.
  • Be a female subject and aged between 18 and 70 years.
  • Provide a core needle biopsy which is histologically confirmed as invasive breast cancer. Excisional biopsy or surgical biopsy is not allowed.

For full eligibility, visit ClinicalTrials.gov.

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