Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients
The investigators hypothesize that adjuvant metformin use in breast cancer patients with overweight or pre-diabetes mellitus (DM) may improve their body condition including weight loss.
In this study, the investigators aim to test the efficacy and safety of adjuvant metformin for operable breast cancer patients with overweight or pre-DM.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
- Weight loss [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Control: Receive placebo pill once every evening on 1~2 weeks.
Receive placebo pill in every morning and evening on 3~24 weeks (twice a day).
Active Comparator: Metformin 500 mg/d
Metformin 500 mg/d
Metformin 500 mg/d: Receive oral metformin 500 mg dose once daily on 1~2 weeks.
Receive placebo pill in every morning and oral metformin 500 mg in every evening on 3~24 weeks.
Active Comparator: Metformin 1000 mg/d
Metformin 1000 mg/d
Metformin 1000 mg/d : Receive oral metformin 500 mg dose once daily on 1~2 weeks. (Dose-escalate)
Receive oral metformin 500 mg in every morning and evening on 3~24 weeks (metformin 500 mg * twice a day = 1000 mg per day).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909506
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Wonshik Han, M.D., Ph.D.||Department of General Surgery, Seoul National University College of Medicine & Seoul National University Hospital|