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NCT02258451 · ClinicalTrials.gov registry record · Phase 2
Study of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus in Subjects With Bone Predominant HER2 Negative Hormone Receptor Positive Metastatic Breast Cancer
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 283
- Enrollment target
NCT02258451: Completed Phase 2 study, sponsored by Bayer.
NCT02258451 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 283 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (113% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02258451, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 283 participants
- Enrollment target
Study Summary
The objective of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated with exemestane and everolimus After implementation of CSP Amendment 10, only a limited number of subjects will remain in this study, in order to reduce the burden to study subjects, collection of data will be reduced and will focus mainly on acute safety, SSE, and OS. Once subjects are rolled over, the long-term safety will be collected and assessed entirely in the separate extended safety follow-up study.
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. Per Protocol Amendment 10, following primary analysis completion, further
Interventions
- DRUG Exemestane
- DRUG Everolimus
- DRUG Radium-223 dichloride (Xofigo, BAY88-8223)
- DRUG Placebo (saline)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 283 participants |
| Start Date | 2015-06-04 |
| Est. Completion | 2022-10-28 |
| Phase | Phase 2 |
What the finished NCT02258451 record still lists
NCT02258451 is an interventional study that assigns participants to a tested intervention. The registered 283 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 (113% higher).
The record links to 0 conditions, and to 4 interventions - of which Exemestane is the first listed.
NCT02258451 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02258451 about?
NCT02258451 is a clinical study titled "Study of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus in Subjects With Bone Predominant HER2 Negative Hormone Receptor Positive Metastatic Breast Cancer". The objective of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated with exemestane and everolimus After implementation of CSP Amendment 1...
What is the current status of trial NCT02258451?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 283 participants. The study started on 2015-06-04. Estimated completion is 2022-10-28.
What interventions are being tested in trial NCT02258451?
The interventions under investigation include: Exemestane (DRUG), Everolimus (DRUG), Radium-223 dichloride (Xofigo, BAY88-8223) (DRUG), Placebo (saline) (DRUG).
Who is sponsoring clinical trial NCT02258451?
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 NCT02258451's enrollment target sits among peer trials
283 195th of 2000 higher than 1,806 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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