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Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients

Primary Purpose

Breast Cancer

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Placebo

Metformin

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Metformin 500 mg/d

Metformin 1000 mg/d

Arm Description

Placebo

Metformin 500 mg/d

Metformin 1000 mg/d

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

Full Information

NCT ID

NCT00909506

First Posted

May 27, 2009

Last Updated

July 27, 2015

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00909506

Brief Title

Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seoul National University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Metformin 500 mg/d

Arm Type

Active Comparator

Arm Description

Metformin 500 mg/d

Arm Title

Metformin 1000 mg/d

Arm Type

Active Comparator

Arm Description

Metformin 1000 mg/d

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

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).

Primary Outcome Measure Information:

Title

Weight loss

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

12. IPD Sharing Statement

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Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients

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