Status:
COMPLETED
Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients
Lead Sponsor:
Seoul National University Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
20+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00909506
Start Date
June 1 2009
End Date
December 1 2011
Last Update
July 29 2015
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744