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NCT02258464 · ClinicalTrials.gov registry record · Phase 2
Study of Radium-223 Dichloride Versus Placebo and Hormonal Treatment as Background Therapy in Subjects With Bone Predominant HER2 (Human Epidermal Growth Factor Receptor 2) Negative Hormone Receptor Positive Metastatic Breast Cancer
A Phase 2 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
NCT02258464: Clinical Trial Phase 2 study, sponsored by Bayer.
NCT02258464 is a Phase 2 study that was terminated before completion, run by Bayer. The registered enrollment target is 99 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02258464, a Phase 2 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
Study Summary
The objective of this study was to assess efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy
Primary Outcome
Time from date of randomization to occurrence of one of the following, whichever happened earlier: 1) an on study SSE, which was defined as the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms, the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral), the occurrence of spinal cord compression, a tumor related orthopedic surgical intervention; or 2) death from any cause
Interventions
- DRUG Radium-223 dichloride (Xofigo, BAY88-8223)
- DRUG Placebo (saline)
- OTHER Background hormonal therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2015-03-02 |
| Est. Completion | 2019-08-13 |
| Phase | Phase 2 |
Why NCT02258464 stopped before completion
NCT02258464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 3 interventions - of which Radium-223 dichloride (Xofigo, BAY88-8223) is the first listed.
NCT02258464 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02258464 about?
NCT02258464 is a clinical study titled "Study of Radium-223 Dichloride Versus Placebo and Hormonal Treatment as Background Therapy in Subjects With Bone Predominant HER2 (Human Epidermal Growth Factor Receptor 2) Negative Hormone Receptor Positive Metastatic Breast Cancer". The objective of this study was to assess efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy
What is the current status of trial NCT02258464?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2015-03-02. Estimated completion is 2019-08-13.
What interventions are being tested in trial NCT02258464?
The interventions under investigation include: Radium-223 dichloride (Xofigo, BAY88-8223) (DRUG), Placebo (saline) (DRUG), Background hormonal therapy (OTHER).
Who is sponsoring clinical trial NCT02258464?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02258464's enrollment target sits among peer trials
99 738th of 2000 higher than 1,258 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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