Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients

NCT00909506 | Completed Phase 2

• 1 other identifier: adjuvant metformin for BC
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Weight loss

  6 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Metformin 500 mg/d

ACTIVE COMPARATOR

Metformin 500 mg/d

Drug: Metformin

Metformin 1000 mg/d

ACTIVE COMPARATOR

Metformin 1000 mg/d

Drug: Metformin

Interventions

Placebo DRUG

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).

Placebo

Metformin DRUG

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 500 mg/d

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Wonshik Han, M.D., Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2009
• First Posted: May 28, 2009
• Study Start: June 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 29, 2015

Record last verified: 2010-09

Locations

KR (1)