Phase I Trial: Adjuvant Alpha-lactalbumin Vaccine in High-Risk TNBC

Case Comprehensive Cancer Center is evaluating the safety and optimal dosing of an α‑lactalbumin vaccine combined with zymosan in a Phase I trial targeting non-metastatic triple-negative breast cancer patients at high risk of recurrence. The study enrolls three cohorts: one treating patients with TNBC using a standard 3+3 dose-escalation design, a preventive group for high‐risk individuals planning prophylactic mastectomy, and a cohort receiving the vaccine alongside adjuvant pembrolizumab following standard chemo-immunotherapy, with vaccinations administered every 2 weeks.