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

NCT01980823 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: AAAM2306
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Breast Tumors; Cancer of Breast

Keywords

Breast Cancer; Metformin; Atorvastatin; Ki-67

Outcome Measures

Primary Outcomes (1)

• Change in tissue levels of the proliferation marker Ki-67

  Tumor proliferation, as measured by the natural log expression of Ki-67 staining of breast tumor cells.

  Baseline, 2 weeks after start of treatment

Study Arms (1)

Metformin-Atorvastatin combination

EXPERIMENTAL

Patients will receive metformin and atorvastatin for approximately 2 weeks prior to breast surgery.

Drug: Metformin; Drug: Atorvastatin; Procedure: Breast surgery

Interventions

Metformin DRUG

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.

Also known as: Glucophage

Metformin-Atorvastatin combination

Atorvastatin DRUG

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.

Also known as: Lipitor

Metformin-Atorvastatin combination

Breast surgery PROCEDURE

(Non-experimental) Female subjects with histologically-confirmed operable invasive breast cancer or DCIS will undergo core needle biopsy with a plan of surgical excision.

Also known as: No other name

Metformin-Atorvastatin combination

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center - Herbert Irving Cancer Center

New York, New York, 10032, United States

Location

Related Links

• Herbert Irving Comprehensive Cancer Center (HICCC) Clinical Trials Page

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Metformin; Atorvastatin; Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Mastectomy; Surgical Procedures, Operative

Study Officials

• Katherine Crew, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 11, 2013
• Study Start: October 1, 2013
• Primary Completion: May 24, 2018
• Study Completion: December 1, 2022
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

US (1)