Nab-Paclitaxel, Durvalumab, Tremelimumab and Neoantigen Vaccine for Metastatic Triple Negative Breast Cancer

This clinical trial focuses on treating patients with metastatic triple negative breast cancer (TNBC), a challenging form of cancer that does not have receptors commonly targeted by existing treatments. The study compares two treatment combinations: one includes nab-paclitaxel, durvalumab, tremelimumab, and a neoantigen vaccine, while the other omits the vaccine. The trial aims to see if adding the vaccine improves the treatment response and overall safety. This research is important because it explores new ways to enhance immune response and potentially offer better outcomes for patients with this aggressive cancer. Participants in the trial will receive treatments through intravenous infusions, which are given on specific days across multiple cycles. In the first phase, all patients receive standard chemotherapy. They are then randomly assigned to one of two groups for the second phase of the study. One group receives the combination with the neoantigen vaccine, and the other without. The study measures how long patients live without the cancer getting worse, known as progression-free survival, and evaluates the immune response and safety of the treatments. Regular imaging tests, biopsies, and blood samples are collected to monitor progress and potential side effects. Follow-up visits occur every three months for a year, and then annually.