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Keep this study
Lead
Seoul National University Hospital
To identify the anti-tumor effect of metformin with preoperatively given letrozole in postmenopausal estrogen receptor positive breast cancer patients
Age
18–80
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Estrogen receptor positive breast cancer
Clinically measurable tumor size(stage II/III)
No evidence of distant metastasis
Postmenopause women 'Age≥60yr' OR 'previous bilateral oophorectomy' OR 'FSH\>30 with no bleeding history within 1yr'
ECOG 0-2
Adequate hepatorenal, bone marrow function 'serum Cr\<1.4mg/dL' AND 'Bilirubin\< upper limit of normal x 1.5 AND 'AST/ALT \< upper limit of normal x 1.8 AND 'ALP \< upper limit of normal x 1.8 AND 'Hemoglobin \>10 g/dL' AND 'ANC \>1,500/mm3' AND 'Platelet \>100,000/mm3'
Spontaneous signed into the written informed consent
History of other carcinoma
Uncontrolled infection
History of psychiatric, epileptic disease
Male breast cancer
Diabetes 'HbA1c≥6.5' OR 'FBS≥126mg/dL'
Hypersensitivity or intolerance to metformin
Risk of metformin associated lactic acidosis 'Congestive heart disease of NYHA Class llll/IV' OR 'History of other acidosis' OR 'Alcohol intake more than either 3 bottles beer OR 1 bottle Soju'
During medication of metformin, sulfonylureas, thiazolidinediones, insulin
Diffuse microcalcification in mammogram
Multiple OR bilateral OR inflammatory breast cancer
Chemotherapy or endocrine therapy within 2yr due to history of breast cancer
Clareo Health | Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer