骨転移が優位なHER2陰性ホルモン受容体陽性転移性乳がん患者を対象とした、ラジウム223ジクロリドとエキセメスタンおよびエベロリムスの併用療法とプラセボとエキセメスタンおよびエベロリムスの併用療法との比較研究

基本情報

NCT ID

NCT02258451

ステータス

完了

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

283

治験依頼者名

Bayer

概要

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.

対象疾患

介入

依頼者（Sponsor）