OncoMatch/Clinical Trials/NCT06631092
Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Neoadjuvant Triple-negative Breast Cancer
Is NCT06631092 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Oral DNA Vaccine for triple negative breast cancer.
Treatment: Oral DNA Vaccine — Phase I/II, multicenter, open-label, single-arm trial in triple-negative breast cancer patients under first-line neoadjuvant therapy with approved standard of care anti-PD-1 monoclonal antibody (PD-1 inhibitor), epirubicin/cyclophosphamide chemotherapy, and nab-paclitaxel therapy (cohort 1) or SoC carboplatin/paclitaxel and epirubicin/cyclophosphamide or doxorubicin/cyclophosphamide chemotherapy (cohort 2). NECVAX-NEO1 treatment in addition to standard of care anti-PD1 monoclonal antibody therapy can be prolonged after breast cancer surgery for another 24 weeks, according to the investigator's decision taking into consideration the study patient's health status.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Disease stage
Required: Stage CT2-4 N0, ANY N-POSITIVE, STAGE II, STAGE III
cT2-4 N0 or any N-positive (stage II-III) triple-negative breast cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L (benign cyclical neutropenia: WBC ≥ 1.5 × 10^9/L, ANC ≥ 1.0 × 10^9/L, leukocytes ≥ 4.0 × 10^9/L, lymphocytes ≥ 0.6 × 10^9/L); platelets ≥ 100 × 10^9/L; hemoglobin ≥ 9 g/dL (may have been transfused)
Kidney function
eGFR ≥ 30 mL/min using 2021 CKD-EPI creatinine equation
Liver function
total bilirubin level ≤1.5×ULN (Gilbert disease allowed if ≤3×ULN); AST/ALT ≤2.5×ULN (≤5×ULN with liver mets)
adequate bone marrow function...adequate hepatic function...adequate renal function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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