Targeting triple negative BREAst cancer metabolism with a combination of chemoimmunotherapy and a FASTing-like approach in the preoperative setting: the BREAKFAST 2 trial.

Co-PI: Dott. Claudio Vernieri

A multicenter, open-label, two-arm, randomized, non-profit, phase II study to evaluate the antitumor activity of adding a thrice-weekly quasi-fasting approach to chemoimmunotherapy treatment with anthracyclines, taxanes, carboplatin, and pembrolizumab in patients with early-stage TNBC. Patients who are eligible and enrolled in the study will be randomized in a 1:1 ratio to the standard treatment arm (arm A) or the experimental quasi-fasting treatment arm (arm B). At randomization, patients will be stratified by clinical stage of disease (II vs. III) in order to ensure a balance of clinical stages in the two experimental arms.