Pre-Surgical Study: Effect of Metformin on Breast Cancer Proliferation

Summary

The purpose of this pilot study is to use a pre surgical intervention model to evaluate the biologic effects of metformin in women with newly diagnosed early invasive breast cancer. Metformin is a drug commonly used to treat patients with diabetes. This model will be used to evaluate the effects of metformin.

Timeline

Start

2009-10-16

Primary completion

2012-05-10

Completion

2017-01-09

Outcome

Missed primary endpoint

registry analysis (other test); Metformin; p = 0.98; Mean Difference (Final Values) -0.006; paired t-test NCT00930579 ↗

paper There was no reduction in ln(ki-67) after metformin (p = .98) PMID 24605899 ↗

Publications

• Kalinsky K, Zheng T, Hibshoosh H, Du X, Mundi P, Yang J, Refice S, Feldman SM, Taback B, Connolly E, Crew KD, Maurer MA, Hershman DL. Proteomic modulation in breast tumors after metformin exposure: results from a "window of opportunity" trial. Clin Transl Oncol. 2017 Feb;19(2):180-188. doi: 10.1007/s12094-016-1521-1. Epub 2016 Jun 15.
• Kalinsky K, Crew KD, Refice S, Xiao T, Wang A, Feldman SM, Taback B, Ahmad A, Cremers S, Hibshoosh H, Maurer M, Hershman DL. Presurgical trial of metformin in overweight and obese patients with newly diagnosed breast cancer. Cancer Invest. 2014 May;32(4):150-7. doi: 10.3109/07357907.2014.889706. Epub 2014 Mar 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	1500 mg	Oral

Indications