OncoMatch/Clinical Trials/NCT05981014
Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer
Is NCT05981014 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for breast neoplasms.
Treatment: Doxorubicin · Epirubicin · Cyclophosphamide · Cyclophosphamide · Fludarabine · Tumor-draining lymph node-derived lymphocyte (LNL) · Interleukin-2 · Nab-paclitaxel — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (0-1+ by IHC or 2+ by IHC without HER2 amplification by FISH) (0-1+ by IHC or 2+ by IHC without HER2 amplification by FISH)
HER2-negative breast cancer, defined as 0-1+ by immunohistochemistry or 2+ by immunohistochemistry without HER2 amplification by FISH
Disease stage
Excluded: Stage IV
The minimum size of the primary tumor was 1 cm in largest diameter by breast MRI, N0-3, M0.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anthracycline (doxorubicin, epirubicin) — neoadjuvant
Have received two cycles of doxorubicin or epirubicin, plus cyclophosphamide, and had stable disease (SD) confirmed by breast MRI
Must have received: alkylating agent (cyclophosphamide) — neoadjuvant
Have received two cycles of doxorubicin or epirubicin, plus cyclophosphamide, and had stable disease (SD) confirmed by breast MRI
Cannot have received: chemotherapy
Exception: except two cycles of doxorubicin or epirubicin, plus cyclophosphamide
Have not received prior therapies for breast cancer, including but not limited to, chemotherapy (except two cycles of doxorubicin or epirubicin, plus cyclophosphamide), radiotherapy, hormonal therapy, targeted therapy, biological therapy and surgery
Cannot have received: radiation therapy
Have not received prior therapies for breast cancer, including but not limited to, chemotherapy (except two cycles of doxorubicin or epirubicin, plus cyclophosphamide), radiotherapy, hormonal therapy, targeted therapy, biological therapy and surgery
Cannot have received: hormonal therapy
Have not received prior therapies for breast cancer, including but not limited to, chemotherapy (except two cycles of doxorubicin or epirubicin, plus cyclophosphamide), radiotherapy, hormonal therapy, targeted therapy, biological therapy and surgery
Cannot have received: targeted therapy
Have not received prior therapies for breast cancer, including but not limited to, chemotherapy (except two cycles of doxorubicin or epirubicin, plus cyclophosphamide), radiotherapy, hormonal therapy, targeted therapy, biological therapy and surgery
Cannot have received: biological therapy
Have not received prior therapies for breast cancer, including but not limited to, chemotherapy (except two cycles of doxorubicin or epirubicin, plus cyclophosphamide), radiotherapy, hormonal therapy, targeted therapy, biological therapy and surgery
Cannot have received: surgery
Have not received prior therapies for breast cancer, including but not limited to, chemotherapy (except two cycles of doxorubicin or epirubicin, plus cyclophosphamide), radiotherapy, hormonal therapy, targeted therapy, biological therapy and surgery
Cannot have received: sentinel lymph node biopsy
Participants have not received sentinel lymph node biopsy (SLNB) and ipsilateral axillary lymph node dissection (ALND) for the breast cancer lesion
Cannot have received: axillary lymph node dissection
Participants have not received sentinel lymph node biopsy (SLNB) and ipsilateral axillary lymph node dissection (ALND) for the breast cancer lesion
Cannot have received: anthracycline (doxorubicin, epirubicin)
Exception: except two cycles of doxorubicin or epirubicin, plus cyclophosphamide
Has received the study-related drugs including anthracycline, cyclophosphamide, taxane, fludarabine, interleukin-2, except two cycles of doxorubicin or epirubicin, plus cyclophosphamide
Cannot have received: alkylating agent (cyclophosphamide)
Exception: except two cycles of doxorubicin or epirubicin, plus cyclophosphamide
Has received the study-related drugs including anthracycline, cyclophosphamide, taxane, fludarabine, interleukin-2, except two cycles of doxorubicin or epirubicin, plus cyclophosphamide
Cannot have received: taxane
Has received the study-related drugs including anthracycline, cyclophosphamide, taxane, fludarabine, interleukin-2, except two cycles of doxorubicin or epirubicin, plus cyclophosphamide
Cannot have received: purine analog (fludarabine)
Has received the study-related drugs including anthracycline, cyclophosphamide, taxane, fludarabine, interleukin-2, except two cycles of doxorubicin or epirubicin, plus cyclophosphamide
Cannot have received: interleukin-2 (interleukin-2)
Has received the study-related drugs including anthracycline, cyclophosphamide, taxane, fludarabine, interleukin-2, except two cycles of doxorubicin or epirubicin, plus cyclophosphamide
Cannot have received: angiogenesis inhibitor (bevacizumab)
Has received long half-life angiogenesis inhibitors within four weeks prior to enrollment, e.g., bevacizumab
Lab requirements
Blood counts
ANC ≥1.5×10^9/L; Lymphocyte count >0.5×10^9/L; Platelets ≥100×10^9/L; Hemoglobin ≥90 g/L
Kidney function
Calculated creatinine clearance (CrCL) ≥45 mL/min OR creatinine ≤1.5 × ULN
Liver function
AST and ALT ≤2.5 ×ULN (≤5×ULN for participants with liver metastases); ALP ≤2.5 ×ULN (≤5×ULN for participants with liver or bone metastases); Total bilirubin ≤1.5×ULN (≤3.0 mg/dL for participants with Gilbert's syndrome)
Cardiac function
Left ventricular ejection fraction (LVEF) ≥50%
Demonstrate adequate normal organ function: ... see full criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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