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NCT02028221 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk
A Phase 2 study, sponsored by University of Arizona.
- Completed
- Registry status
- Phase 2
- Development phase
- 151
- Enrollment target
NCT02028221: Completed Phase 2 study, sponsored by University of Arizona.
NCT02028221 is a Phase 2 study that has completed, run by University of Arizona. The registered enrollment target is 151 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02028221, a Phase 2 study, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 151 participants
- Enrollment target
Study Summary
Overweight and obesity are well established risk factors for breast cancer that develop after menopause. The increased postmenopausal breast cancer risk in women who are overweight or obese is likely to be attributed to multiple metabolic disturbances. Metformin is a commonly used medication in diabetics to stabilize blood sugar. Association studies and laboratory studies have shown its potential to reduce the risk for development of cancer, including breast cancer. Recent pilot clinical studies in breast cancer patients suggest that metformin may only be effective in overweight or obese women with metabolic disturbances. We propose to conduct a clinical study of metformin in overweight or obese premenopausal women with metabolic disturbances. Study participants will be randomly assigned to receive metformin or placebo for 12 months. The study will evaluate whether metformin can result in favorable changes in risk features that have been associated with increased breast cancer risk. The risk features that will be examined in our study include breast density, certain proteins and hormones, products of body metabolism, and body weight and composition. The study should help determine the potential breast cancer preventive activity of metformin in a growing population at risk for multiple diseases.
Primary Outcome
change of dense breast volume at 6 months
Interventions
- DRUG Placebo
- DRUG Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2014-03-07 |
| Est. Completion | 2022-06-14 |
| Phase | Phase 2 |
What the finished NCT02028221 record still lists
NCT02028221 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02028221 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02028221 about?
NCT02028221 is a clinical study titled "Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk". Overweight and obesity are well established risk factors for breast cancer that develop after menopause. The increased postmenopausal breast cancer risk in women who are overweight or obese is likely to be attributed to multiple metabolic disturbances. Metformin is a commonly used medication in diab...
What is the current status of trial NCT02028221?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 151 participants. The study started on 2014-03-07. Estimated completion is 2022-06-14.
What interventions are being tested in trial NCT02028221?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG).
Who is sponsoring clinical trial NCT02028221?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02028221's enrollment target sits among peer trials
151 454th of 2000 higher than 1,546 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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