CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 283 enrolled
Drug / intervention
Radium-223 dichloride (Xofigo, BAY88-8223) +3 moredrug
Likely dose
Exemestane 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02258451
NCT02258451Phase 2Completed
CompareCT.gov

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

Bayer·interventional·Posted Oct 7, 2014·Updated Nov 24, 2023

In Brief

A Phase 2 clinical trial evaluating Radium-223 dichloride (Xofigo, BAY88-8223), Placebo (saline), and 2 other interventions for Breast Neoplasms. Completed, enrolled 283 participants across 92 sites in 17 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesAustria, Belgium, France, Germany, Hong Kong, Israel, Italy, Japan, Norway, Poland, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 7, 2014
Enrollment StartJun 4, 2015
Primary CompletionJan 22, 2020
Study CompletionOct 28, 2022
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 11.7 years ago

Interventions

Radium-223 dichloride (Xofigo, BAY88-8223)drug

Up to 6 cycles of radium-223 dichloride 50kBq/kg body (55 kBq/kg after implementation of NIST update)

Placebo (saline)drug

Up to 6 cycles of saline injection

Exemestanedrug

One 25 mg tablet once daily after a meal.

Everolimusdrug

The recommended dose of everolimus administered in the study is 10 mg once daily with or without food. Starting dose, dose modifications, and administration of exemestane and everolimus must be in compliance with the local labels in each of the participating countries and/or in line with local standard of practice.