The Use of Metformin in Early Breast Cancer Patients Pre-Surgery

Study Overview
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Brief Summary
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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
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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

Official Title
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The Use of Metformin in Early Breast Cancer Patients Pre-Surgery: A Phase 0 Study Regarding The Biological Effect

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Metformin Pre-Surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin Pre-Surgery<br>Patients will take metformin twice a day for three weeks prior surgery | Drug: Metformin Pre-Surgery<br>* 500 mg tablet, taken twice a day for 3 weeks<br>* Other names: Blood and tissue collection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To analyse gastrointestinal toxicity | To analyse gastrointestinal toxicity grade (examples: nausea, stomach pain, vomiting) Number of Participants with Adverse Events | One week , 2 weeks and 20 days after Metformim beginning | 
| To analyse the blood tests one day before the biopsy and one day before the surgery | -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 | 5 days after blood collection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Metformin, Pre-Surgery