Pre-Surgical Trial of the Combination of Metformin and Atorvastatin in Newly Diagnosed Operable Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01980823|
Recruitment Status : Recruiting
First Posted : November 11, 2013
Last Update Posted : July 15, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Breast Tumors Cancer of Breast||Drug: Metformin Drug: Atorvastatin Procedure: Breast surgery||Early Phase 1|
Breast cancer cells require energy homeostasis shifts with enhanced anabolism to enable rapid growth and continued proliferation. The main energy regulatory system in eukaryotes and breast cancer cells is the AMP-activated kinase (AMPK) pathway. AMPK is triggered by changes in the AMP/Adenosine triphosphate (ATP) ratio thus impacting energy reserves and requirements. AMPK pathway closely interacts with the phosphoinositide 3-kinase (PI3K)/Akt signaling pathway, affecting the downstream function of the master regulator mammalian target of rapamycin (mTOR). Activation of AMPK has been shown in vitro to result in inhibition of proliferation of various cancer cell lines.
Utilizing a pre-surgical model, the investigator plans to conduct a pilot study of 40 women with newly diagnosed invasive breast cancer or ductal carcinoma in-situ (DCIS) who will receive oral metformin and atorvastatin daily in the interval between diagnostic breast biopsy and definitive breast surgery.
The goal is to determine if dual combination treatment with metformin plus atorvastatin significantly impacts tumor-based markers, such as proliferation, and blood-based biomarkers.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pre-Surgical "Window of Opportunity" Trial of the Combination of Metformin and Atorvastatin in Newly Diagnosed Operable Breast Cancer|
|Actual Study Start Date :||October 2013|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||December 2021|
Experimental: Metformin-Atorvastatin combination
Patients will receive metformin and atorvastatin for approximately 2 weeks prior to breast surgery.
Metformin is an oral diabetes medicine that helps control blood sugar levels.
Dosage/Frequency: 1500 mg per day: divided 500 mg in the morning and 1000 mg in the evening
Metformin is for people with type 2 diabetes. Metformin is sometimes used in combination with insulin or other medications, but it is not for treating type 1 diabetes.
Other Name: Glucophage
Atorvastatin is in a group of drugs called "statins." Atorvastatin reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).
Dosage/Frequency: 80 mg once a day at bedtime
Atorvastatin is used to treat high cholesterol, and to lower the risk of stroke, heart attack, or other heart complications in people with type 2 diabetes, coronary heart disease, or other risk factors.
Other Name: Lipitor
Procedure: Breast surgery
(Non-experimental) Female subjects with histologically-confirmed operable invasive breast cancer or DCIS will undergo core needle biopsy with a plan of surgical excision.
Other Name: No other name
- Change in tissue levels of the proliferation marker Ki-67 [ Time Frame: Baseline, 2 weeks after start of treatment ]Tumor proliferation, as measured by the natural log expression of Ki-67 staining of breast tumor cells.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980823
|Contact: Lisa Olmos, RNfirstname.lastname@example.org|
|United States, New York|
|Columbia University Medical Center - Herbert Irving Cancer Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Kevin Kalinsky, MD email@example.com|
|Principal Investigator: Kevin Kalinsky, MD|
|Principal Investigator:||Kevin Kalinsky, MD||Columbia University|