Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer

Summary

This randomized phase III trial studies metformin hydrochloride to see how well it works compared to placebo in preventing breast cancer in patients with atypical hyperplasia or in situ breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of metformin hydrochloride may prevent breast cancer.

Timeline

Start

2015-11-23

Primary completion

2023-11-10

Completion

2026-11

Outcome

Missed primary endpoint

registry analysis (superiority test); Arm I vs Arm II; p = 0.951; Odds Ratio (OR) 0.97 (95% CI 0.36 to 2.62); Chi-squared NCT01905046 ↗

Drugs

Indications