Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00909506|
Recruitment Status : Completed
First Posted : May 28, 2009
Last Update Posted : July 29, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Placebo Drug: Metformin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||December 2011|
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).
- Weight loss [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|