NCT00909506
Completed
Phase 2
Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Breast Cancer
- Sponsor
- Seoul National University Hospital
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Weight loss
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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, the investigators aim to test the efficacy and safety of adjuvant metformin for operable breast cancer patients with overweight or pre-DM.
Investigators
Eligibility 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
Arms & Interventions
Placebo
Placebo
Intervention: Placebo
Metformin 500 mg/d
Metformin 500 mg/d
Intervention: Metformin
Metformin 1000 mg/d
Metformin 1000 mg/d
Intervention: Metformin
Outcomes
Primary Outcomes
Weight loss
Time Frame: 6 months
Study Sites (1)
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