Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01980823 · ClinicalTrials.gov registry record · Early Phase 1
Pre-Surgical Trial of the Combination of Metformin and Atorvastatin in Newly Diagnosed Operable Breast Cancer
A Early Phase 1 study, sponsored by Columbia University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 23
- Enrollment target
NCT01980823: Completed Early Phase 1 study, sponsored by Columbia University.
NCT01980823 is a Early Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 23 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01980823, a Early Phase 1 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the effects of combining metformin and atorvastatin treatment in patients with newly diagnosed breast cancer during the interval between breast biopsy and surgery. This study is designed to assess whether tumor proliferation, as measured by the natural log expression of Ki-67 staining of breast tumor cells, is reduced following approximately 2 weeks of treatment with the combination of metformin plus atorvastatin in patients with newly diagnosed breast cancer.
Primary Outcome
Tumor proliferation, as measured by the natural log expression of Ki-67 staining of breast tumor cells.
Interventions
- DRUG Metformin
- DRUG Atorvastatin
- PROCEDURE Breast surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2013-10 |
| Est. Completion | 2022-12 |
| Phase | Early Phase 1 |
What the finished NCT01980823 record still lists
NCT01980823 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 3 interventions - of which Metformin is the first listed.
NCT01980823 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01980823 about?
NCT01980823 is a clinical study titled "Pre-Surgical Trial of the Combination of Metformin and Atorvastatin in Newly Diagnosed Operable Breast Cancer". The purpose of this study is to determine the effects of combining metformin and atorvastatin treatment in patients with newly diagnosed breast cancer during the interval between breast biopsy and surgery. This study is designed to assess whether tumor proliferation, as measured by the natural log ...
What is the current status of trial NCT01980823?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 23 participants. The study started on 2013-10. Estimated completion is 2022-12.
What interventions are being tested in trial NCT01980823?
The interventions under investigation include: Metformin (DRUG), Atorvastatin (DRUG), Breast surgery (PROCEDURE).
Who is sponsoring clinical trial NCT01980823?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01980823's enrollment target sits among peer trials
23 1088th of 2000 higher than 898 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03616041 · 23 participants
Capsule Endoscopy for Severe Hematochezia
- NCT04348747 · 23 participants · Phase 2
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
- NCT04587687 · 23 participants · Phase 2
Brentuximab Vedotin and Bendamustine for the Treatment of Relapsed or Refractory Follicular Lymphoma
- NCT04715022 · 23 participants · Phase 1
Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia