None listed
Conditions
Interventions
Drug : Patients will be randomly assigned to receive 24 weeks of neoadjuvant treatment with letrozole (2.5mg/day) and either metformin (2000mg/day) or placebo. Target accrual is 104 patients in each a
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)ER-positive =10% nuclear staining by immunohistochemistry , Allred score=3 2)T stage II or III 3)no distant metastasis 4)lower than 80years old, menopausal status (over 60 years old, or bilateral oophorectomy state, or if less than 60 years old, no mensturation during last 1 year and FSH higher than 30mIU/mL) 5)ECOG score 0-2 6)good functioning myeloid (Hemoglobin >10 g/dL, ANC >1,500/mm3, platelet >100,000/mm3) 7)serum Cr <=1.4 mg/dL 8)liver function (bilirubin=1.5*upper normal limit, AST/ALT=1.8*upper normal limit, ALP=1.8*upper normal limit) 9)the person who participate in this clinical trial himself and had written informed consent
Exclusion criteria
Exclusion criteria: 1)not measurable primary tumor clinically 2)N3 or T4 3)confirmed distant metastasis 4)the patient who have other cancers or not have been 5years after the treatment of other cancer 5)uncontrollable infectious disease 6)psychotic disorder or epilepsy 7)male breast cancer 8)poor general condition unable to understand or submit informed consent 9)diabetes mellitus (HbA1c=6.5 or FBS=126mg/dL) 10)hypersensitivity or intolerance to metformin 11)high risk patients for lactic acidosis associated with metformin - congestive heart disease (New York Heart Association (NYHA) Class llll/IV grade) - past medical history of acidosis - habitus alcoholics 12)current user of metformin, sulfonylureas, thiazolidenediones, insulin 13)diffuse microcalcification on mammography 14)multicentric, bilateral or inflammatory breast cancer 15)contralateral breast cancer who had chemotherapy or anti-hormonal therapy in 2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of tumor response (clinical response rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;Ki-67 level and genomoc profile analysis in core needle biopsy specimen at 4week;Breast Conserving Rate;Percent mammographic density;Toxicity profile of letrozole and metformin | — |
Countries
Korea, Republic of
Contacts
Public ContactJisun Kim
Seoul National University Hospital
Outcome results
None listed