NeoMET Study in Neoadjuvant Treatment of Breast Cancer

NCT01929811 ↗

Phase 2 Terminated 92 enrolled Shanghai Jiao Tong University School of Medicine

RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate docetaxel, epirubicin and cyclophosphomide (TEC) with TEC plus metformin in neoadjuvant treatment of breast cancer patients. The aim is to evaluate whether metformin can increase the pCR rate combination with TEC regimen in neoadjuvant setting.

Timeline

Start: 2013-10
Primary completion: 2020-06
Completion: 2020-06

Outcome

Missed primary endpoint

Stopped (Enrollment): “Slow enrollment.”

paper The tpCR rates were 12.5% (5/40) and 14.6% (7/48) in the TEC and TECM groups, respectively (P = 0.777). PMID 36525180 ↗

Publications

Huang J, Tong Y, Hong J, Huang O, Wu J, He J, Chen W, Li Y, Chen X, Shen K. Neoadjuvant docetaxel, epirubicin, and cyclophosphamide with or without metformin in breast cancer patients with metabolic abnormality: results from the randomized Phase II NeoMET trial. Breast Cancer Res Treat. 2023 Feb;197(3):525-533. doi: 10.1007/s10549-022-06821-y. Epub 2022 Dec 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	500 mg	Oral
Background	Cyclophosphamide	Other / unclassified	500 mg/m2	Intravenous
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous
Background	Epirubicin	Small molecule	75 mg/m2	Intravenous

Indications

No indication recorded.