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Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00909506
First received: May 27, 2009
Last updated: September 17, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Drug: Placebo
Drug: Metformin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 105
Study Start Date: June 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
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).

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909506

Contacts
Contact: Wonshik Han, M.D., Ph.D. 82-2-2072-1958 hanw@snu.ac.kr
Contact: Sue K. Park, M.D., Ph.D. 82-2-740-8338 suepark@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Wonshik Han, M.D., Ph.D.     82-2-2072-1958     hanw@snu.ac.kr    
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Wonshik Han, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00909506     History of Changes
Other Study ID Numbers: adjuvant metformin for BC
Study First Received: May 27, 2009
Last Updated: September 17, 2010
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013