OncoMatch/Clinical Trials/NCT06631092
Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Neoadjuvant Triple-negative Breast Cancer
Is NCT06631092 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06631092 currently recruiting?
Yes, this trial is currently recruiting patients.
What disease stage is eligible?
Stage CT2-4 N0 or ANY N-POSITIVE or STAGE II or STAGE III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify