Abstract
BACKGROUND: Cancer vaccines offer an innovative approach to treating advanced breast cancer, by activating the immune system to recognize and target cancer cells, aiming to boost immune response, reduce relapse, and enhance patients' quality of life. METHODS: A systematic database search was conducted for peer-reviewed, full-text articles on clinical trials focused on cancer vaccines for advanced breast cancer, in the MEDLINE, SCOPUS, Cochrane and ClinicalTrials.gov databases, from conception until October 23, 2024. RESULTS: A total of 19 trials, involving 747 patients with advanced breast cancer, were included in this systematic review. Cancer vaccine trials rely primarily on immunological endpoints, with initial small-scale studies showing modest efficacy improvements and highly variable immune response rates (44-100%), suggesting opportunities for further optimization and broader clinical application. CONCLUSION: While the overall quality of the studies was acceptable, heterogeneity in results and limited survival or progression outcomes prevented data synthesis. In conclusion, despite promising findings, the lack of large-scale randomized trials limits definitive conclusions on cancer vaccine efficacy, highlighting the need for Phase III trials to confirm their clinical utility and long-term impact.