Pre-Surgical Study: Effect of Metformin on Breast Cancer Proliferation

Breast Cancer Clinical Trial

Official title:

Phase II Pre-Surgical Intervention Study for Evaluating the Effect of Metformin on Breast Cancer Proliferation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930579
• Other study ID #: AAAD6525
• Status: Completed
• Phase: Phase 2
• Start date: October 16, 2009
• Est. completion date: January 9, 2017

Study information

• Verified date: October 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this pilot study is to use a pre surgical intervention model to evaluate the biologic effects of metformin in women with newly diagnosed early invasive breast cancer. Metformin is a drug commonly used to treat patients with diabetes. This model will be used to evaluate the effects of metformin.

Description:

Breast cancer is the most common cancer and the second leading cause of cancer death among women in the United States. Several epidemiologic studies have found an increased risk of breast cancer in women with type 2 diabetes. This association appears to be mediated by a state of hyperinsulinemia and insulin resistance. Population based studies have also found a decreased risk of cancer in diabetic patients taking metformin, an oral biguanide derivative. Proposed mechanisms include its effect on lowering serum insulin levels as well as modulation of cellular signaling pathways which inhibit tumor cellular proliferation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 9, 2017
• Est. primary completion date: May 10, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Histologically-confirmed operable invasive breast cancer or ductal carcinoma in situ (DCIS) who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment

• Body mass index > 25

• Age = 21 years

• No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry

• Signed informed consent

Exclusion Criteria:

• History of diabetes mellitus requiring medical therapy

• Treatment with other investigational drugs within 6 months of study entry

• Significant renal impairment with a creatinine > 1.4 mg/dl

• Other serious intercurrent medical illness

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Metformin
1500 mg per day, divided 500 mg in the morning and 1000 mg in the evening, for at least two weeks prior to surgery

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Breast Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Proliferation in Tumor Specimens	This outcome measure examines the changes in tumor proliferation as measured by the amount of Ki-67 protein in the tumor.	Baseline, up to 4 weeks