Know Cancer

forgot password

Phase 2
20 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

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

Type of Study:


Study Design:

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

Outcome Measure:

Weight loss

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Wonshik Han, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of General Surgery, Seoul National University College of Medicine & Seoul National University Hospital


Korea: Food and Drug Administration

Study ID:

adjuvant metformin for BC



Start Date:

June 2009

Completion Date:

December 2011

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms