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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin Pre-Surgery | Experimental | Patients will take metformin twice a day for three weeks prior surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin Pre-Surgery | Drug | 500 mg tablet, taken twice a day for 3 weeks |
|
| 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
| 60 days after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| To analyse gastrointestinal toxicity |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Elisa Lohmann, MD | Instituto Nacional de Cancer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital do Cancer III | Rio de Janeiro | Rio de Janeiro | 20560-120 | Brazil |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D014015 | Tissue Banks |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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-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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D018070 | Biological Specimen Banks |
| D006268 | Health Facilities |
| D005159 | Health Care Facilities Workforce and Services |