Placebo controlled Radium-223, plus exemestane and everolimus in mBC

• Research type

  Research Study

• Full 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.

• IRAS ID

  161878

• Contact name

  Amit Bahl

• Contact email

  Amit.Bahl@uhbw.nhs.uk

• Sponsor organisation

  Bayer HealthCare AG

• Eudract number

  2014-002114-23

• Research summary

  Patients with metastatic breast cancer with bone involvement whose breast cancer is HER2 negative and ER positive are treated with exemestane and everolimus. These patients will be invited to participate on this study. The purpose of this study is to understand if adding radium-223 dichloride to exemestane and everolimus helps patients to delay the occurrence of symptomatic skeletal events. Patients will be randomly given one of the following treatments: radium­ 223 dichloride 50 kBq/kg or placebo (normal saline), in addition to exemestane and everolimus. The study will be double blind, which means neither the patient nor their doctor will know which treatment option the patient is on. The main objective of this study is to assess efficacy and safety of radium-223 dichloride in combination with exemestane and everolimus in subjects with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor positive breast cancer with bone metastases.

  About 310 patients, from approximately 25 countries are anticipated to participate in this study.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  14/SW/1085

• Date of REC Opinion

  6 Feb 2015

• REC opinion

  Further Information Favourable Opinion