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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. Identifier: NCT00909506
Recruitment Status : Completed
First Posted : May 28, 2009
Last Update Posted : July 29, 2015
Information provided by (Responsible Party):
Seoul National University Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : June 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Placebo Comparator: Placebo
Drug: 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
Drug: Metformin

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
Drug: Metformin

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).

Primary Outcome Measures :
  1. Weight loss [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Operable Breast cancer patients with BMI ≥ 23 or 100 ≤ FBS < 126
  • From 6 month to 2 years since breast cancer operation and at least 4 weeks since chemotherapy or radiotherapy
  • No drug use except Tamoxifen
  • Normal OTPT & Serum creatinine (<=ULN)
  • ECOG performance status 0-2 or Karnofsky PS 60-100%
  • Life expectancy > 12
  • Absolute neutrophil count ≥ 1.5 x 10^9/L
  • Platelets ≥ 100 x 10^9/L
  • Pregnancy(-) & without plan for pregnancy
  • Sign a written informed consent form

Exclusion Criteria:

  • Type I or II DM or concurrent use of DM control agents
  • Prior use of Metformin
  • Hypoglycemia (FBS< 70 with clinical symptom)
  • Concurrent investigational or commercial agents
  • Other diet or drug intervention for weight loss
  • Concurrent use of steroid
  • Abnormal liver and/or renal function
  • Symptomatic congestive heart failure / Cardiac arrhythmia / Angina pectoris
  • Ongoing or active infection
  • lactic acidosis
  • Pregnancy or ongoing breast feeding
  • Anorexia, bulimia, nausea due to other disease for longer than 1 month
  • Allergies or allergic reactions attributed to oral medications
  • Inability to swallow or digest oral medications
  • Physical or psychiatric illness that would limit compliance with study protocol
  • Participants in other clinical trial

Information from the National Library of Medicine

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 identifier (NCT number): NCT00909506

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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
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Principal Investigator: Wonshik Han, M.D., Ph.D. Department of General Surgery, Seoul National University College of Medicine & Seoul National University Hospital
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Responsible Party: Seoul National University Hospital Identifier: NCT00909506    
Other Study ID Numbers: adjuvant metformin for BC
First Posted: May 28, 2009    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: September 2010
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Hypoglycemic Agents
Physiological Effects of Drugs