Metformin Pre-Surgical Pilot Study

Overview[ - collapse ][ - ]

Purpose 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.
ConditionBreast Cancer
InterventionDrug: Metformin
PhasePhase 2
SponsorColumbia University
Responsible PartyColumbia University
ClinicalTrials.gov IdentifierNCT00930579
First ReceivedJune 29, 2009
Last UpdatedJuly 30, 2013
Last verifiedJuly 2013

Tracking Information[ + expand ][ + ]

First Received DateJune 29, 2009
Last Updated DateJuly 30, 2013
Start DateOctober 2009
Estimated Primary Completion DateMarch 2014
Current Primary Outcome MeasuresEffects of metformin on AMPK/mTOR signaling pathway [Time Frame: 2 weeks] [Designated as safety issue: Yes]
Current Secondary Outcome MeasuresReduction of fasting serum insulin levels [Time Frame: 2 weeks] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleMetformin Pre-Surgical Pilot Study
Official TitlePhase II Pre-Surgical Intervention Study for Evaluating the Effect of Metformin on Breast Cancer Proliferation
Brief 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.
Detailed Description
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.
Study TypeInterventional
Study PhasePhase 2
Study DesignEndpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionBreast Cancer
InterventionDrug: 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
Other Names:
Metformin
Study Arm (s)Experimental: Metformin

Recruitment Information[ + expand ][ + ]

Recruitment StatusActive, not recruiting
Estimated Enrollment35
Estimated Completion DateMarch 2014
Estimated Primary Completion DateOctober 2011
Eligibility Criteria
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
GenderFemale
Ages25 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00930579
Other Study ID NumbersAAAD6525
Has Data Monitoring CommitteeYes
Information Provided ByColumbia University
Study SponsorColumbia University
CollaboratorsBreast Cancer Research Foundation
Investigators Principal Investigator: Dawn L Hershman, MD Columbia University
Verification DateJuly 2013

Locations[ + expand ][ + ]

Columbia University Medical Center
New York, New York, United States, 10032