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Completed

NCT Number: NCT00930579

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

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

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

Other names: Metformin hydrochloride

Primary outcomes

  1. Tumor Proliferation in Tumor Specimens

    Time frame: Baseline, up to 4 weeks

    This outcome measure examines the changes in tumor proliferation as measured by the amount of Ki-67 protein in the tumor.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Breast Cancer Research Foundation

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2017
First posted
Jun 30, 2009
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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