OncRef

Clinical Trial: NCT01101438

A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Canadian Cancer Trials Group
Information Provided By:Canadian Cancer Trials Group
Last Update Posted:2023-09-13

Study Overview

Brief 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.

Official Title

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

Conditions

Breast Cancer

Intervention / Treatment

  • Drug: metformin hydrochloride
  • Other: placebo

Other Study ID Numbers

  • MA32
  • U10CA077202
  • CAN-NCIC-MA.32
  • CDR0000669788

Start Date (Actual)

2010-08-13

Primary Completion Date (Actual)

2021-09-21

Study Completion Date (Actual)

2023-08-18

Enrollment (Actual)

3649

Study Type

Interventional

Phase

Phase 3