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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Atypical Ductal Breast Hyperplasia, BRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ

In brief

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.

Key facts

Study ID

NCT01905046

Run by

Alliance for Clinical Trials in Oncology

People needed

86

Starts

2015-11-23

Expected to finish

2026-11-01

Last updated by the study team

2026-04-28

Who can join

Age: 25 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• Other active malignancy =< 5 years prior to pre-registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment, i.e., other hormonal therapy, for their cancer
• Body mass index (BMI) < 25
• Receiving Warfarin
• Bilateral breast implants or autologous breast flap reconstruction
• Active diagnosis of alcoholism
• Contraindication to metformin prevention such as acute hypersensitivity or allergic reaction to metformin
• Currently receiving tamoxifen or raloxifene
• Administration of any investigational agent =< 30 days prior to pre-registration
• Previous radiation to both breasts
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Receiving pyrimethamine, cimetidine, rifampin or cephalexin
• Women who have a core biopsy or excisional biopsy containing invasive cancer
• Women who have taken metformin within the past 90 days
• Patients with hemoglobin a1c > 6.3 or who are being actively treated for diabetes

Where it is running

• 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

Full record on ClinicalTrials.gov

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