Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

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

NCT01905046 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • OTHER placebo
  • DRUG metformin hydrochloride

Study Locations (20)

South Carolina

  • Prisma Health Cancer Institute - Spartanburg — Boiling Springs
  • Prisma Health Cancer Institute - Easley — Easley
  • Greenville Health System Cancer Institute-Andrews — Greenville
  • Prisma Health Cancer Institute - Butternut — Greenville
  • Prisma Health Cancer Institute - Faris — Greenville

California

  • City of Hope Comprehensive Cancer Center — Duarte
  • Los Angeles County-USC Medical Center — Los Angeles
  • USC / Norris Comprehensive Cancer Center — Los Angeles
  • City of Hope South Pasadena — South Pasadena

New York

  • Roswell Park Cancer Institute — Buffalo
  • Mount Sinai Hospital — New York
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center — New York

Kansas

  • University of Kansas Cancer Center — Kansas City
  • Cotton O'Neil Cancer Center / Stormont Vail Health — Topeka

Ohio

  • The Christ Hospital — Cincinnati
  • Ohio State University Comprehensive Cancer Center — Columbus

Indiana

  • The Community Hospital — Munster

Minnesota

  • Mayo Clinic in Rochester — Rochester

North Carolina

  • Duke University Medical Center — Durham

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2015-11-23
Est. Completion 2025-11
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01905046

The ClinicalTrials.gov registry entry for NCT01905046 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Ductal Breast Carcinoma in Situ appearing as the primary indexed condition, and to 2 interventions — of which placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01905046 reports 20 study locations spanning 9 distinct geographic areas — top geographies include South Carolina, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01905046 about?

NCT01905046 is a clinical study titled "Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer". 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 hydro...

What is the current status of trial NCT01905046?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 86 participants. The study started on 2015-11-23. Estimated completion is 2025-11.

What conditions does trial NCT01905046 study?

This clinical trial studies the following conditions: Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, BRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Atypical Ductal Breast Hyperplasia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01905046?

The interventions under investigation include: placebo (OTHER), metformin hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01905046?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01905046 being conducted?

This trial has 20 study locations across California, Indiana, Kansas, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial