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

NCT01905046 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-04-28

Study results available
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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.

Conditions

  • Atypical Ductal Breast Hyperplasia
  • BRCA1 Mutation Carrier
  • BRCA2 Mutation Carrier
  • Ductal Breast Carcinoma in Situ
  • Lobular Breast Carcinoma in Situ

Interventions

DRUG

metformin hydrochloride

given PO

OTHER

placebo

given PO

Sponsors & Collaborators

Principal Investigators

  • Victoria Seewaldt, MD · City of Hope Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-23
Primary Completion
2023-11-10
Completion
2026-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01905046 on ClinicalTrials.gov