drugset / Trial / NCT04387630
Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.
RandomizedParallel-groupOpen-labelTreatment
Summary
Metformin is a widely used anti-diabetic drug. Several studies have pointed out a potentially beneficial effect of metformin therapy in diabetic cancer patients. Several studies are investigating the anti-tumor effect of metformin in early breast cancer. However, the enhancing effect of metformin on anti-tumor immunity has only been demonstrated in animal models. This study examines the immune effect of metformin in breast cancer patients treated with preoperative chemotherapy.
Timeline
- Start
- 2020-06-05
- Primary completion
- 2022-06-05
- Completion
- 2023-05-01
Publications
- Background Eikawa S, Nishida M, Mizukami S, Yamazaki C, Nakayama E, Udono H. Immune-mediated antitumor effect by type 2 diabetes drug, metformin. Proc Natl Acad Sci U S A. 2015 Feb 10;112(6):1809-14. doi: 10.1073/pnas.1417636112. Epub 2015 Jan 26.
- Background Pearce EL, Walsh MC, Cejas PJ, Harms GM, Shen H, Wang LS, Jones RG, Choi Y. Enhancing CD8 T-cell memory by modulating fatty acid metabolism. Nature. 2009 Jul 2;460(7251):103-7. doi: 10.1038/nature08097. Epub 2009 Jun 3.
- Background Coyle C, Cafferty FH, Vale C, Langley RE. Metformin as an adjuvant treatment for cancer: a systematic review and meta-analysis. Ann Oncol. 2016 Dec;27(12):2184-2195. doi: 10.1093/annonc/mdw410. Epub 2016 Sep 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 2550 mg | Oral |