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CompletedNCT00909506Updated Jul 29, 2015

Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients

A Phase 2 interventional study of Placebo and Metformin in Breast Cancer, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-07-29.

Sponsored by Seoul National University Hospital · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
20 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 105 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
105 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

  • Active comparator
    Metformin 500 mg/d

    Metformin 500 mg/d

    Drug: Metformin

  • Active comparator
    Metformin 1000 mg/d

    Metformin 1000 mg/d

    Drug: Metformin

Interventions

  • DrugPlacebo

    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).

  • DrugMetformin

    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.

  • DrugMetformin

    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).

06

What researchers measure

Primary outcomes

  1. Weight loss

    Time frame: 6 months

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00909506
Lead sponsor
Seoul National University Hospital
Responsible party
Sponsor
First posted
May 28, 2009
Start date
Jun 2009
Primary completion
Mar 2011
Completion
Dec 2011
Last update
Jul 29, 2015

Study contacts

Wonshik Han, M.D., Ph.D.
principal investigator · Department of General Surgery, Seoul National University College of Medicine & Seoul National University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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