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ACTIVE NOT RECRUITING
NCT01905046
PHASE3

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

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

25 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

86

Start Date

2015-11-23

Completion Date

2025-11

Last Updated

2025-04-13

Healthy Volunteers

No

Interventions

DRUG

metformin hydrochloride

given PO

OTHER

placebo

given PO

Locations (27)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Los Angeles County-USC Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

The Community Hospital

Munster, Indiana, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

Cotton O'Neil Cancer Center / Stormont Vail Health

Topeka, Kansas, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Mount Sinai Hospital

New York, New York, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

The Christ Hospital

Cincinnati, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

Prisma Health Cancer Institute - Easley

Easley, South Carolina, United States

Greenville Health System Cancer Institute-Andrews

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

M D Anderson Cancer Center

Houston, Texas, United States

Doctor's Hospital of Laredo

Laredo, Texas, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States