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NCT01952054 · ClinicalTrials.gov registry record · Phase 2
Denosumab for Breast Cancer With Bone Mets
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT01952054: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01952054 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01952054, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if denosumab in combination with a hormonal drug can help lower the number of circulating tumor cells (CTCs) in patients with breast cancer that has spread to the bone. The safety of this combination will also be studied. This is an investigational study. Denosumab is FDA approved and commercially available to prevent bone-related events caused by breast cancer that has spread to the bone. Using denosumab to lower CTCs in patients with breast cancer that has spread to the bone is investigational. You may have the option of continuing denosumab after the study ends. Up to 35 patients will take part in this study. All will be enrolled at MD Anderson.
Primary Outcome
The difference in number of CTCs in 7.5 ml whole blood from baseline to week4. CTC reduction from baseline to week4 is statistically analyzed using the two-sided paired t-test with the significance level of 0.05.
Interventions
- DRUG Denosumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2015-02-09 |
| Est. Completion | 2018-10-10 |
| Phase | Phase 2 |
Why NCT01952054 stopped before completion
NCT01952054 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Denosumab is the first listed.
NCT01952054 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01952054 about?
NCT01952054 is a clinical study titled "Denosumab for Breast Cancer With Bone Mets". The goal of this clinical research study is to learn if denosumab in combination with a hormonal drug can help lower the number of circulating tumor cells (CTCs) in patients with breast cancer that has spread to the bone. The safety of this combination will also be studied. This is an investigation...
What is the current status of trial NCT01952054?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2015-02-09. Estimated completion is 2018-10-10.
What interventions are being tested in trial NCT01952054?
The interventions under investigation include: Denosumab (DRUG).
Who is sponsoring clinical trial NCT01952054?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01952054's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 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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