NCT01101438

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,649 (actual)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter study. Patients are stratified according to hormone-receptor status (estrogen receptor- and/or progesterone receptor- positive vs both receptors negative), body mass index (≤ 30 vs \> 30 kg/m²), HER2 status (positive vs negative), and prior chemotherapy (any vs none). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral metformin hydrochloride twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive oral placebo twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity. Blood and tumor samples are collected periodically for correlative studies. Patients may complete quality-of-life, physical activity, and diet questionnaires at baseline and at 6, 12, 24, 36, 48, and 60 months. (Sub-set of patients). After completion of study treatment, patients are followed annually.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	metformin hydrochloride	Given orally
OTHER	placebo	Given orally

Timeline

• Start date: 2010-08-13
• Primary completion: 2021-09-21
• Completion: 2023-08-18
• First posted: 2010-04-12
• Last updated: 2023-09-13
• Results posted: 2022-10-18

Locations

344 sites across 4 countries: United States, Canada, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study