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Metformin and Atorvastatin in Treating Patients with Newly Diagnosed Breast Cancer That Can Be Removed by Surgery

Trial Status: Complete

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.

Inclusion Criteria

  • Subjects with histologically-confirmed operable invasive breast cancer or ductal carcinoma in situ (DCIS), who undergo core needle biopsy with a plan of surgical excision (goal: approximately 2 weeks of study medications after enrollment)
  • >= 5 mm by imaging/pathology of core to ensure enough pre- and post-treatment tissue for analysis
  • No prior chemotherapy, radiation therapy, or breast resection within 6 months of study entry
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Signed informed consent

Exclusion Criteria

  • Currently on medication for diabetes or hypercholesterolemia
  • Treatment with other investigational drugs within 6 months of study entry
  • Strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP 3A4) inhibitors (e.g., clarithromycin, human immunodeficiency virus [HIV] protease inhibitors, and itraconazole), given potential interactions with atorvastatin (atorvastatin calcium)
  • Renal impairment with a creatinine > 1.4 mg/dl
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) >= 2.5 x upper limit of normal range (ULN), OR
  • Total bilirubin >= 1.5 x ULN (subjects with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN), OR
  • Alkaline phosphatase > 2.5 x ULN

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Contact: Katherine D. Crew
Phone: 212-305-1732


I. To evaluate the biologic effects of the dual therapy on the proliferation marker Ki-67.


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.


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.

Trial Phase Phase O

Trial Type Treatment

Lead Organization
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center

Principal Investigator
Katherine D. Crew

  • Primary ID AAAM2306
  • Secondary IDs NCI-2014-01506, Y1M00
  • ID NCT01980823