Breast Cancer
Conditions
Keywords
Breast Cancer, Metformin, Pre-Surgery
Brief 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
Interventions
DRUGMetformin Pre-Surgery
500 mg tablet, taken twice a day for 3 weeks
Sponsors
Instituto Nacional de Cancer, Brazil
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the in situ effects of metformin in women with operable stage I or II breast cancer | 60 days after the surgery | 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(+). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To analyse gastrointestinal toxicity | One week , 2 weeks and 20 days after Metformim beginning | * To analyse gastrointestinal toxicity grade (examples: nausea, stomach pain, vomiting) * Number of Participants with Adverse Events |
| To analyse the blood tests one day before the biopsy and one day before the surgery | 5 days after blood collection | -To collect and analyze pre- and post-treatment peripheral blood specimens for serum glucose, glycosylated haemoglobin and insulin levels, as well as circulating IGF-1 and estradiol |
Countries
Brazil
Outcome results
None listed