Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909506
• Other study ID #: adjuvant metformin for BC
• Status: Completed
• Phase: Phase 2
• First received: May 27, 2009
• Last updated: July 27, 2015
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: September 2010
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		6 months	Yes