The Use of Metformin in Early Breast Cancer Patients Pre-Surgery
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Breast Cancer, Metformin, Pre-Surgery
Study Type
Interventional
Study Phase
Phase 0
Study Design
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Intervention
Name: Metformin Pre-Surgery
Type: Drug
Overall Status
Recruiting
Summary
The study will test metformin in patients with early breast cancer. Blood and tissue will be collected before and after the use of metformin.
Detailed Description
Patients will take metformin twice a day for 3 weeks before surgery. The hypothesis is that metformin will reduce cell proliferation rates (Ki67) and increase apoptoses (TUNEL)in tumor tissue.

The study will collect and analyze pre- and post-treatment blood specimens for:

- Serum glucose

- Insulin levels

- Estradiol

- HOMA test

- Glycosylated haemoglobin
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Invasive breast cancer T1 or T2, Nx

- Knowledge of the investigational nature of the study and ability to provide consent for study participation

Exclusion Criteria:

- Diabetes or baseline glucose or Glycosylated haemoglobin upper limit of normal for the institution

- Recent use of corticosteroids

- AST > 1.5 times upper limit of normal for the institution

- Pregnancy

- Serious clinical illness

- Prior or concurrent systemic neoadjuvant Breast Cancer therapy.
Location
Hospital do Cancer III
Rio de Janeiro, Brazil
Status: Recruiting
Contact: Ana Elisa Lohmann, MD - 55-21-3879-6110 - anaelisalohmann@gmail.com
Start Date
January 2011
Completion Date
December 2011
Sponsors
Instituto Nacional de Cancer, Brazil
Source
Instituto Nacional de Cancer, Brazil
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page