Study of Radium-223 Dichloride Versus Placebo and Hormonal Treatment as Background Therapy in Subjects With Bone Predominant HER2 (Human Epidermal Growth Factor Receptor 2) Negative Hormone Receptor Positive Metastatic Breast Cancer

Summary

The objective of this study was to assess efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy

Timeline

Start

2015-03-02

Primary completion

2019-08-13

Completion

2019-08-13

Outcome

Missed primary endpoint

Stopped (Enrollment): “Due to lower than expected recruitment since the start of study”

registry Radium 223 Dichloride vs Placebo; p = 0.3339; Hazard Ratio (Radium 223/Placebo) 0.745 (80% CI 0.504 to 1.102) NCT02258464 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Radium-223 dichloride	Other / unclassified	0.05 mbq/kg	Intravenous
Subject	Radium-223 dichloride	Other / unclassified	0.055 mbq/kg	Intravenous

Indications