Phase II Randomized Study of Neoadjuvant Metformin Plus Letrozole vs Placebo Plus Letrozole for ER-positive Postmenopausal Breast Cancer
To identify the anti-tumor effect of metformin with preoperatively given letrozole in
postmenopausal estrogen receptor positive breast cancer patients
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Clinical response rate
Comparing with RECIST 1.1 From baseline to 24week(after completing medication, preoperatively)
24week(after completing medication, preoperatively)
Yes
Wonshik Han, MD PhD
Principal Investigator
Seoul National University Hospital
South Korea: Institutional Review Board
KBCSG 013
NCT01589367
May 2012
April 2015
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