Metformin and Nightly Fasting in Women With Early Breast Cancer

Summary

This phase IIb trial studies the combined effect of prolonged nightly fasting and metformin hydrochloride extended release in decreasing breast tumor cell proliferation and other biomarkers of breast cancer. Preventing invasive breast cancer or DCIS. Metformin is widely used to treat type II diabetes and is associated with a decreased risk of cancer and death in diabetic individuals. Intermittent fasting may protect cancer patients from the toxic effects of chemotherapy agents without causing chronic weight loss. The combination of intermittent fasting and metformin may reduce breast cancer growth and may be used in women at risk for breast cancer or other cancers associated with being overweight.

Timeline

Start

2023-04-04

Primary completion

2025-12-09

Completion

2026-12-16

Publications

• Briata IM, Spinaci S, Thomas PS, Serrano D, Buttiron Webber T, Gandolfo N, Guasone F, Rattaro A, Firpo E, D'amico M, Rutigliani M, Oliva M, Gualco M, Peresi M, Uncini S, Guerrieri-Gonzaga A, Johansson H, Gandini S, Lazzeroni M, Accornero CA, Pala O, Minucci S, Intra M, Veronesi P, Vornik LA, Garcia-Gonzalez A, Lozano MC, Heckman-Stoddard BM, Dimond E, Sauter ER, Vilar E, Bonanni B, DeCensi A. Time-Restricted Eating and Metformin in Invasive Breast Cancer or DCIS: A Randomized, Phase IIb, Presurgical Trial. Preliminary Safety Analysis. Cancer Prev Res (Phila). 2026 Jan 6;19(1):25-32. doi: 10.1158/1940-6207.CAPR-25-0104.

Drugs

Indications