๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-04-09

Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer (NCT01905046)

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

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Alliance for Clinical Trials in Oncology

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: City of Hope Comprehensive Cancer Center โ€” Duarte, California

Age range: 25 Years to 55 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (27 Sites)

Showing the first 25 of 27 sites.

  • City of Hope Comprehensive Cancer Center โ€” Duarte, California
  • Los Angeles County-USC Medical Center โ€” Los Angeles, California
  • USC / Norris Comprehensive Cancer Center โ€” Los Angeles, California
  • City of Hope South Pasadena โ€” South Pasadena, California
  • The Community Hospital โ€” Munster, Indiana
  • University of Kansas Cancer Center โ€” Kansas City, Kansas
  • Cotton O'Neil Cancer Center / Stormont Vail Health โ€” Topeka, Kansas
  • Mayo Clinic in Rochester โ€” Rochester, Minnesota
  • Roswell Park Cancer Institute โ€” Buffalo, New York
  • Mount Sinai Hospital โ€” New York, New York
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center โ€” New York, New York
  • Duke University Medical Center โ€” Durham, North Carolina
  • The Christ Hospital โ€” Cincinnati, Ohio
  • Ohio State University Comprehensive Cancer Center โ€” Columbus, Ohio
  • University of Oklahoma Health Sciences Center โ€” Oklahoma City, Oklahoma
  • Prisma Health Cancer Institute - Spartanburg โ€” Boiling Springs, South Carolina
  • Prisma Health Cancer Institute - Easley โ€” Easley, South Carolina
  • Greenville Health System Cancer Institute-Andrews โ€” Greenville, South Carolina
  • Prisma Health Cancer Institute - Butternut โ€” Greenville, South Carolina
  • Prisma Health Cancer Institute - Faris โ€” Greenville, South Carolina
  • Prisma Health Greenville Memorial Hospital โ€” Greenville, South Carolina
  • Prisma Health Cancer Institute - Eastside โ€” Greenville, South Carolina
  • Prisma Health Cancer Institute - Greer โ€” Greer, South Carolina
  • Prisma Health Cancer Institute - Seneca โ€” Seneca, South Carolina
  • M D Anderson Cancer Center โ€” Houston, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (800) 826-4673

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—