drugset / Trial / NCT01980823

Pre-Surgical Trial of the Combination of Metformin and Atorvastatin in Newly Diagnosed Operable Breast Cancer

NCT01980823

Phase 0 Completed 23 enrolled Columbia University
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the effects of combining metformin and atorvastatin treatment in patients with newly diagnosed breast cancer during the interval between breast biopsy and surgery. This study is designed to assess whether tumor proliferation, as measured by the natural log expression of Ki-67 staining of breast tumor cells, is reduced following approximately 2 weeks of treatment with the combination of metformin plus atorvastatin in patients with newly diagnosed breast cancer.

Timeline

Start
2013-10
Primary completion
2018-05-24
Completion
2022-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 80 mg
Subject Metformin Small molecule 1500 mg Oral

Indications