Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Neoadjuvant Triple-negative Breast Cancer
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Patients able to understand and follow instructions during the trial. 2. Patients able and willing to give written informed consent, signed and dated. 3. Female and male patients. 4. Patients aged at least 18 years old at the time of ICF signature. 5. cT2-4 N0 or any N-positive (stage II-III) triple-negative breast cancer patients diagnosed as candidates for neoadjuvant anti-PD1 monoclonal antibody and anthracycline/taxane based chemotherapy 6. Patients with tumor accessible for biopsy and surgery and showing at least 30% of tumoral cells on the biopsy. 7. Patients with adequate bone marrow function at Screening, confirmed at Baseline, including: 1. ANC ≥ 1.5 × 109/L; patients with documented benign cyclical neutropenia are eligible if white blood cell count is ≥ 1.5 × 109/L, with ANC ≥ 1.0 × 109/L, leukocytes ≥ 4.0 × 109/L, and lymphocytes ≥ 0.6 × 109/L; 2. platelets ≥ 100 × 109/L; 3. hemoglobin ≥ 9 g/dL (may have been transfused); 8. International Normalized Ra