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Active, not recruiting Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01905046

Public ClinicalTrials.gov record NCT01905046. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 3:21 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Testing for Atypia in Random Periareolar Fine Needle Aspiration (RPFNA) Cytology After 12 Months Metformin (1, 1-Dimethylbiguanide Hydrochloride) Chemoprevention Versus Placebo Control in Premenopausal Women

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This phase III trial studies how well metformin hydrochloride 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.

Study identification

NCT ID
NCT01905046
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Enrollment
86 participants

Conditions and interventions

Eligibility (public fields only)

Age range
25 Years to 55 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 23, 2015 (Actual)
Primary completion
Nov 10, 2023 (Actual)
Completion
Nov 2026 (Estimated)
Last update posted
Oct 8, 2026

2015 – 2026

United States locations

U.S. sites
27
U.S. states
11
U.S. cities
21
Facility City State ZIP Site status
City of Hope Comprehensive Cancer Center Duarte California 91010 —
Los Angeles County-USC Medical Center Los Angeles California 90033 —
USC / Norris Comprehensive Cancer Center Los Angeles California 90033 —
City of Hope South Pasadena South Pasadena California 91030 —
The Community Hospital Munster Indiana 46321 —
University of Kansas Cancer Center Kansas City Kansas 66160 —
Cotton O'Neil Cancer Center / Stormont Vail Health Topeka Kansas 66606 —
Mayo Clinic in Rochester Rochester Minnesota 55905 —
Roswell Park Cancer Institute Buffalo New York 14263 —
Mount Sinai Hospital New York New York 10029 —
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York 10032 —
Duke University Medical Center Durham North Carolina 27710 —
The Christ Hospital Cincinnati Ohio 45219 —
Ohio State University Comprehensive Cancer Center Columbus Ohio 43210 —
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 —
Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina 29316 —
Prisma Health Cancer Institute - Easley Easley South Carolina 29640 —
Greenville Health System Cancer Institute-Andrews Greenville South Carolina 29601 —
Prisma Health Cancer Institute - Butternut Greenville South Carolina 29605 —
Prisma Health Cancer Institute - Faris Greenville South Carolina 29605 —
Prisma Health Greenville Memorial Hospital Greenville South Carolina 29605 —
Prisma Health Cancer Institute - Eastside Greenville South Carolina 29615 —
Prisma Health Cancer Institute - Greer Greer South Carolina 29650 —
Prisma Health Cancer Institute - Seneca Seneca South Carolina 29672 —
M D Anderson Cancer Center Houston Texas 77030 —
Doctor's Hospital of Laredo Laredo Texas 78041 —
University of Wisconsin Carbone Cancer Center Madison Wisconsin 53792 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01905046, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 8, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01905046 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →