NCT05981014 Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer
| NCT ID | NCT05981014 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Condition | Breast Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 196 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2030-12-31 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: In order to be eligible for participation in this trial, the participant must: 1. Have signed the informed consent to study participation. 2. Be a female subject and aged between 18 and 70 years. 3. Provide a core needle biopsy which is histologically confirmed as invasive breast cancer. Excisional biopsy or surgical biopsy is not allowed. 4. Have received two cycles of doxorubicin or epirubicin, plus cyclophosphamide, and had stable disease (SD) confirmed by breast MRI. 5. Have breast cancer defined as the following combined primary tumor (T), regional lymph node (N), and distant metastasis (M) staging per AJCC for breast cancer staging criteria version 8 based on breast MRI assessment: The minimum size of the primary tumor was 1 cm in largest diameter by breast MRI, N0-3, M0. 6. Have HER2-negative breast cancer, defined as 0-1+ by immunohistochemistry or 2+ by immunohistochemistry without HER2 amplification by FISH. 7. Have known hormone receptor status (estrogen