Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients
NCT ID: NCT00909506
Last Updated: 2015-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
105 participants
INTERVENTIONAL
2009-06-30
2011-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Placebo
Placebo
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).
Metformin 500 mg/d
Metformin 500 mg/d
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.
Metformin 1000 mg/d
Metformin 1000 mg/d
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).
Interventions
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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).
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.
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 Criteria
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Inclusion Criteria
* 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
* 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
20 Years
FEMALE
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Wonshik Han, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of General Surgery, Seoul National University College of Medicine & Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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adjuvant metformin for BC
Identifier Type: -
Identifier Source: org_study_id
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