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
Public ClinicalTrials.gov record NCT02258451. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus When Administered to Metastatic HER2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02258451
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 283 participants
Conditions and interventions
Conditions
Interventions
- Radium-223 dichloride (Xofigo, BAY88-8223) Drug
- Placebo (saline) Drug
- Exemestane Drug
- Everolimus Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 4, 2015 (Actual)
- Primary completion
- Jan 22, 2020 (Actual)
- Completion
- Oct 28, 2022 (Actual)
- Last update posted
- Nov 24, 2023
2015 – 2022
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | La Jolla | California | 92093 | — |
| Not listed | Los Angeles | California | 90033 | — |
| Not listed | New Haven | Connecticut | 6510 | — |
| Not listed | Hollywood | Florida | 33021 | — |
| Not listed | Ashland | Kentucky | 41101 | — |
| Not listed | Rockville | Maryland | 20850 | — |
| Not listed | Ann Arbor | Michigan | 48109 | — |
| Not listed | Detroit | Michigan | 48202 | — |
| Not listed | Pontiac | Michigan | 48341 | — |
| Not listed | Rochester | Minnesota | 55905 | — |
| Not listed | St Louis | Missouri | 63110 | — |
| Not listed | Newark | New Jersey | 07103 | — |
| Not listed | Jamaica | New York | 11432 | — |
| Not listed | Watertown | South Dakota | 57201 | — |
| Not listed | Spokane | Washington | 99208-1129 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 77 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02258451, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 24, 2023 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02258451 live on ClinicalTrials.gov.