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Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients

NCT00909506 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2015-07-29

No results posted yet for this study

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

Interventions

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).

DRUG

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.

DRUG

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).

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Wonshik Han, M.D., Ph.D. · Department of General Surgery, Seoul National University College of Medicine & Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-03-31
Completion
2011-12-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00909506 on ClinicalTrials.gov