Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT01589367
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* Who does not meet the above inclusion criteria
* 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01589367
Study Brief:
Protocol Section:
NCT01589367