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NCT01905046 · ClinicalTrials.gov registry record · Phase 3
Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer
A Phase 3 study of Ductal Breast Carcinoma in Situ and Lobular Breast Carcinoma in Situ, sponsored by Alliance for Clinical Trials in Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 86
- Enrollment target
- 20
- Study locations
NCT01905046: Active Phase 3 study of Ductal Breast Carcinoma in Situ and Lobular Breast Carcinoma in Situ, sponsored by Alliance for Clinical Trials in Oncology.
NCT01905046 is a Phase 3 study of Ductal Breast Carcinoma in Situ and Lobular Breast Carcinoma in Situ that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 86 participants, below the 144-participant average among 11 other Ductal Breast Carcinoma in Situ trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01905046, a Phase 3 study of Ductal Breast Carcinoma in Situ and Lobular Breast Carcinoma in Situ, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 86 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Presence of atypia at 12 months is determined through the average of Masood scores across all evaluable breasts for a patient. If the average score is at least 13.5, then patient will be labeled as having atypia. The primary aim of this study is to compare the presence of atypia at month 12 between two arms using the chi-square test in univariable analysis and regressed on group indicator, age, race, stratification factors, and baseline Masood score using logistic regression in multivariable ana
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2015-11-23 |
| Est. Completion | 2025-11 |
| Phase | Phase 3 |
What the registry record for NCT01905046 still lists
NCT01905046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 144-participant average among 11 other Ductal Breast Carcinoma in Situ trials with a reported enrollment target (40% lower).
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.
NCT01905046 names 20 study sites across 9 states, led by South Carolina, California, New York.
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.
What interventions are being tested in trial NCT01905046?
The interventions under investigation include: placebo (OTHER), metformin hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01905046?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT01905046's enrollment target sits among peer trials
86 7th of 11 higher than 5 of 11 other Ductal Breast Carcinoma in Situ trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ductal Breast Carcinoma in Situ trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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