Pre-Surgical “Window of opportunity” trial of the Combination of Metformin and Atorvastatin in Newly Diagnosed Operable Breast Cancer

Protocol: 
AAAM2306
Phase: 
Pilot

Pre-Surgical “Window of opportunity” trial of the Combination of Metformin and Atorvastatin in Newly Diagnosed Operable Breast Cancer

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. Metformin is a medication used to treat patients with diabetes. It has been shown to have anti-tumor properties in breast cancer. Atorvastatin is widely used for the treatment of elevated cholesterol and has also shown to have anti-tumor properties in breast cancer. Both of safely been used in patients without diabetes or elevated cholesterol. This study will assess the impact of combined metformin and atorvastatin combined on breast tumor tissue markers as well as blood levels, including cholesterol and insulin. If you decide to participate in this study, you will receive oral metformin given 500mg in the morning and 1000mg in the evening. Atorvastatin will be given orally 80mg in the evening. Both medications will be given for two weeks prior to your scheduled breast surgery. Approximately 40 subjects will be recruited for this study.

Are you Eligible? (Inclusion Criteria)

To be eligible for this study, patients must:
- be female with confirmed invasive breast cancer
- be age 21 or older
- have no prior chemotherapy, radiation therapy, or breast resection in the
last 6 months

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States