CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,649 enrolled
Drug / intervention
metformin hydrochloride +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01101438
NCT01101438Phase 3Completed

A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer

Canadian Cancer Trials Group·interventional·Posted Apr 12, 2010·Updated Sep 13, 2023

In Brief

A Phase 3 clinical trial evaluating metformin hydrochloride and placebo for Breast Cancer. Completed, enrolled 3,649 participants across 344 sites in 4 countries.

Detailed Summary

This study is looking at whether Metformin, an agent that is commonly used to treat diabetes, can decrease or affect the ability of breast cancer cells to grow and whether Metformin will work with other therapies to keep cancer from recurring. Health Canada has not approved the sale or use of Metformin to treat breast cancer, although they have approved its use in this clinical trial. Although Metformin is approved by the FDA for the treatment of diabetes, its use in breast cancer is considered investigational.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesCanada, Switzerland, United Kingdom, United States

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 12, 2010
Enrollment StartAug 13, 2010
Primary CompletionSep 21, 2021
Study CompletionAug 18, 2023
TodayJul 2, 2026
Enrollment to primary: 11.1 yearsPosted 16.2 years ago

Interventions

metformin hydrochloridedrug

Given orally

placeboother

Given orally