Time-Restricted Eating and Metformin in Invasive Breast Cancer or DCIS: A Randomized, Phase IIb, Presurgical Trial. Preliminary Safety Analysis.

ABSTRACT: Cancer cells exhibit metabolic flexibility between anaerobic glycolysis and oxidative phosphorylation. Preclinical data showed that metformin, an oxidative phosphorylation inhibitor, combined with fasting-induced hypoglycemia led to activation of the PP2A-GSK3ß-Mcl1 axis and inhibition of tumor growth. A window-of-opportunity trial was designed to evaluate the effect of metformin and nightly fasting on proliferation in invasive breast cancer or ductal carcinoma in situ (DCIS). The primary endpoint is the pretreatment/posttreatment change of Ki67 in cancer tissue, and the co-primary endpoint is the difference in posttreatment Ki67 in cancer-adjacent DCIS or high-risk lesions. Participants with hormone receptor-positive invasive breast cancer or DCIS candidates to surgery are being accrued a

SUBMITTER: Briata IM 

PROVIDER: S-EPMC12770929 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature