Metformin and Atorvastatin in Treating Patients with Newly Diagnosed Breast Cancer That Can Be Removed by Surgery
- 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
- 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
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
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Katherine D. Crew
- Primary ID AAAM2306
- Secondary IDs NCI-2014-01506, Y1M00
- Clinicaltrials.gov ID NCT01980823