Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Placebo; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT00909506

adjuvant metformin for BC

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Metformin 500 mg/d

Active Comparator group

Description:

Metformin 500 mg/d

Treatment:

Drug: Metformin

Drug: Metformin

Metformin 1000 mg/d

Active Comparator group

Description:

Metformin 1000 mg/d

Treatment:

Drug: Metformin

Drug: Metformin