Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00909506

Enrollment

105

Registered

2009-05-28

Start date

2009-06-30

Completion date

2011-12-31

Last updated

2015-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

DRUGPlacebo

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).

DRUGMetformin

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Weight loss	6 months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026