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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Treatments: Atorvastatin; Atorvastatin Calcium; Metformin

Criteria

Inclusion Criteria:

• Female subjects with histologically-confirmed operable invasive breast cancer or DCIS, who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment

• ≥ 5 mm by imaging/pathology of core to ensure enough pre- and post-treatment tissue for analysis

• Age ≥ 21 years. Breast cancer is uncommon in patients less than this age.

• 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 3A4 (abbreviated CYP3A4) (e.g., clarithromycin, HIV protease inhibitors, and itraconazole), given potential interactions with atorvastatin

• Renal impairment with a creatinine > 1.4 mg/dl

• Hepatic impairment: Aspartate transaminase (AST)/(SGOT), Alanine Transaminase(ALT)/(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