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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 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 283 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02258451
The ClinicalTrials.gov registry entry for NCT02258451 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 283 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Exemestane is the first listed.
NCT02258451 reports 0 study locations.
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.
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