Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients

July 27, 2015 updated by: Seoul National University Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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
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.

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).
Active Comparator: Metformin 1000 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.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight loss
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Wonshik Han, M.D., Ph.D., Department of General Surgery, Seoul National University College of Medicine & Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 27, 2009

First Submitted That Met QC Criteria

May 27, 2009

First Posted (Estimate)

May 28, 2009

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • adjuvant metformin for BC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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