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


Phase 2
25 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Phase II Pre-Surgical Intervention Study for Evaluating the 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 biguanide derivative which is commonly used to treat patients with diabetes.
This model will be used to evaluate the effects of metformin on a specific molecular pathway
called the AMPK/mTOR signaling pathway in the tumor. The effects of metformin on serum
insulin levels and components of the insulin resistance syndrome will also be studied.


Inclusion Criteria:



- Histologically-confirmed operable invasive breast cancer or 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Effects of metformin on AMPK/mTOR signaling pathway

Outcome Time Frame:

2 weeks

Safety Issue:

Yes

Principal Investigator

Dawn L Hershman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University

Authority:

United States: Institutional Review Board

Study ID:

AAAD6525

NCT ID:

NCT00930579

Start Date:

October 2009

Completion Date:

March 2014

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Columbia University Medical CenterNew York, New York  10032