Clinical trial
Pre-Surgical "Window of Opportunity" Trial of the Combination of Metformin and Atorvastatin in Newly Diagnosed Operable Breast Cancer
Name
AAAM2306
Description
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.
Trial arms
Trial start
2013-10-01
Estimated PCD
2018-05-24
Trial end
2022-12-01
Status
Completed
Phase
Early phase I
Treatment
Metformin
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.
Arms:
Metformin-Atorvastatin combination
Other names:
Glucophage
Atorvastatin
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.
Arms:
Metformin-Atorvastatin combination
Other names:
Lipitor
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.
Arms:
Metformin-Atorvastatin combination
Other names:
No other name
Size
23
Primary endpoint
Change in tissue levels of the proliferation marker Ki-67
Baseline, 2 weeks after start of treatment
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 23, 'type': 'ACTUAL'}}
Updated at
2023-08-30
1 organization
Organization
Columbia University