NCT04170465: Role of Adding Metformin to Neoadjuvant Chemotherapy in Patients With Breast…

Summary

Metformin, the widely prescribed oral hypoglycemic drug, is well known for its established efficacy, favorable safety profile, and low cost. Metformin has recently received increasing attention because of its potential antitumorigenic effects that are thought to be independent of its hypoglycemic effects. It has been extensively studied in preclinical models, which have implicated several molecular pathways in its antitumor activity. Metformin was proved to have anti-proliferative and apoptotic effects on tumor cells.Moreover, metformin enhances the T-cell mediated immune response to tumor tissue and fights metastases. Also, epidemiological studies have shown that metformin, but not other antidiabetic drugs, reduces cancer incidence and improves survivability in diabetic cancer patients. The proposed research in this application will investigate two prime questions with regards to the combined use of metformin together with traditional neoadjuvant chemotherapy in breast cancer patients. First, the hypothesis that the simultaneous use of metformin along with doxorubicin/cyclophosphamide/paclitaxel neoadjuvant protocol produces better antitumor outcomes will be tested. Second, the study will examine if the improved apoptotic effect of such regimen is paralleled by exaggerated stimulatory influences on apoptosis biomarkers.

Timeline

Start: 2019-10-29
Primary completion: 2022-04-02
Completion: 2022-06-28

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	850 mg	Oral
Background	Cyclophosphamide	Other / unclassified	600 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	60 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	80 mg/m2	Intravenous

Role of Adding Metformin to Neoadjuvant Chemotherapy in Patients With Breast Cancer (METNEO)

Summary

Timeline

Publications

Drugs

Indications