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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 is a Phase 2 study that has completed, run by University of Arizona. The registered enrollment target is 151 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02028221
The ClinicalTrials.gov registry entry for NCT02028221 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02028221 reports 0 study locations.
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.
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