The Use of Metformin in Early Breast Cancer Patients Pre-Surgery: A Phase 0 Study Regarding The Biological Effect
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
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
To determine the in situ effects of metformin in women with operable stage I or II breast cancer
To determine the in situ effects of metformin on proliferation (Ki67) and apoptosis (TUNEL), fosforilate AKT CD1a CD83, CD68, F40/80, arginase iNOS and T cells -CD4(+),CD45RA(+), CD 45RO, CD4, CD8 and FOXP3(+).
60 days after the surgery
No
Ana Elisa Lohmann, MD
Principal Investigator
Instituto Nacional de Cancer
Brazil: Ministry of Health
INCA113/10
NCT01302002
January 2011
December 2011
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