This pilot clinical trial studies metformin and atorvastatin in treating patients with newly diagnosed breast cancer that can be removed by surgery. Metformin is a medication used to treat patients with diabetes. Atorvastatin is used for the treatment of elevated cholesterol. Metformin and atorvastatin may have anti-tumor properties in breast cancer. Giving metformin with atorvastatin before surgery may work better in treating patients with breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT01980823.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To evaluate the biologic effects of the dual therapy on the proliferation marker Ki-67.
SECONDARY OBJECTIVE:
I. Tumor assessment of protein kinase, AMP-activated, alpha 1 catalytic subunit (AMPK)/mechanistic target of rapamycin (mTOR) signaling and apoptosis (reverse phase protein array: RPPA) and reduction of fasting markers of the insulin growth factor pathway.
OUTLINE:
Patients receive metformin hydrochloride orally (PO) twice daily (BID) and atorvastatin calcium PO once daily (QD) for approximately 2 weeks through the evening before surgery in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at least within 4 weeks, per physician's discretion.
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Principal InvestigatorKatherine D. Crew
