Preoperative chemotherapy-Fondazione IRCCS Istituto Nazionale dei Tumori, Milano-triple-negative breast cancer

This preoperative (neoadjuvant) treatment regimen is being evaluated in the Phase 2 BREAKFAST trial (NCT04248998) for patients with stage I-III triple-negative breast cancer (TNBC). Conducted by the Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, the intervention combines standard neoadjuvant chemotherapy (four cycles of doxorubicin and cyclophosphamide followed by twelve cycles of weekly paclitaxel) with a cyclic fasting-mimicking diet (FMD), with or without the addition of metformin. The FMD is a plant-based, calorie-restricted diet designed to induce metabolic changes that sensitize cancer cells to chemotherapy while protecting normal tissues. Metformin is included to provide synergistic antitumor effects by concomitantly inhibiting glycolysis and mitochondrial oxidative phosphorylation. The trial aims to improve pathological complete response (pCR) rates by targeting the specific metabolic vulnerabilities of TNBC cells.

Other names

doxorubicin + cyclophosphamide + paclitaxel + fasting-mimicking diet + metforminFMD + metformin + chemotherapyTargeting Triple Negative BREAst Cancer Metabolism With a Combination of Chemotherapy and a Diet Mimicking FASTing Plus/Minus Metformin