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

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.

Timeline

Start

2015-06-04

Primary completion

2020-01-22

Completion

2022-10-28

Publications

• Rugo HS, Van Poznak CH, Neven P, Danielewicz I, Lee SC, Campone M, Chik JYK, Vega Alonso E, Naume B, Brain E, Siegel JM, Li R, Uema D, Wagner VJ, Coleman RE. Radium-223 in women with hormone receptor-positive bone-metastatic breast cancer receiving endocrine therapy: pooled analysis of two international, phase 2, randomized, double-blind, placebo-controlled trials. Breast Cancer Res Treat. 2024 Apr;204(2):249-259. doi: 10.1007/s10549-023-07147-z. Epub 2023 Dec 20.

Drugs

Indications