← Back to Search

Biguanides

metformin hydrochloride for Breast Cancer

Phase 3
Waitlist Available
Led By Pamela J. Goodwin, MD
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

Study Summary

This trial is testing whether Metformin can help treat breast cancer by decreasing the ability of cancer cells to grow, and whether it can work with other therapies to keep cancer from recurring.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Invasive Disease-free Survival
Erbium
Secondary outcome measures
Breast Cancer-specific Mortality
Distant Relapse-free Survival
Overall Survival

Side effects data

From 2023 Phase 3 trial • 3649 Patients • NCT01101438
45%
Diarrhea
45%
Fatigue
39%
Hot flashes
31%
Nausea
27%
Peripheral sensory neuropathy
23%
Insomnia
21%
Arthralgia
18%
Pain in extremity
17%
Headache
16%
Constipation
14%
Pain
14%
Anxiety
13%
Depression
12%
Back pain
12%
Myalgia
11%
Abdominal pain
11%
Hypertension
11%
Alopecia
10%
Anorexia
10%
Dyspepsia
10%
Bloating
9%
Weight loss
9%
Flatulence
9%
Lymphedema
9%
Cough
9%
Dyspnea
8%
Vomiting
8%
Edema limbs
8%
Dizziness
7%
Gastroesophageal reflux disease
7%
Dermatitis radiation
6%
Breast pain
5%
Weight gain
5%
Arthritis
5%
Bone pain
5%
Dysgeusia
5%
Vaginal dryness
4%
Hyperglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Metformin
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm IExperimental Treatment1 Intervention
Patients receive oral metformin hydrochloride twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
Group II: Arm IIPlacebo Group1 Intervention
Patients receive oral placebo twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
metformin hydrochloride
2010
Completed Phase 3
~5940

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,920,840 Total Patients Enrolled
939 Trials studying Breast Cancer
1,539,711 Patients Enrolled for Breast Cancer
ETOP IBCSG Partners FoundationNETWORK
65 Previous Clinical Trials
54,414 Total Patients Enrolled
29 Trials studying Breast Cancer
40,667 Patients Enrolled for Breast Cancer
ICR-CTSUUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer
2010. "A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01101438.
~249 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top