Phase II randomized study of neoadjuvant METformin plus letrozole vs placebo plus letrozole for ER-positive pOstmenopausal bReast cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0000674
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 208
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the rate of tumor response (clinical response rate)
- Secondary Outcome Measures
Name Time Method 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