Efficacy and safety of Radium 223 in mBC, compared to hormone therapy
Research type
Research Study
Full title
A phase II randomized, double-blind, placebo-controlled trial of radium-223 dichloride versus placebo when administered to metastatic HER2 negative hormone receptor positive breast cancer subjects with bone metastases treated with hormonal treatment background therapy.
IRAS ID
161305
Contact name
Robert Coleman
Contact email
Sponsor organisation
Bayer HealthCare AG
Eudract number
2014-002113-39
Duration of Study in the UK
1 years, 9 months, 3 days
Research summary
Patients with human epidermal growth factor receptor 2 negative, hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy will be invited to participate on this study. The purpose of this study is to understand if adding radium-223 dichloride to hormonal therapy helps patients live longer without symptomatic skeletal complications. Patients will be randomly given one of the following treatments: radium-223 dichloride 50 kBq/kg or placebo (normal saline). 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 to see if adding radium-223 dichloride to hormonal therapy is effective and safe in patients with epidermal growth factor receptor 2 negative, hormone receptor positive breast cancer with bone metastases.
About 227 patients, from approximately 24 countries are anticipated to participate in this study.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/1141
Date of REC Opinion
29 Oct 2014
REC opinion
Further Information Favourable Opinion