NCT01070485

BAY88-8223, Alpharadin, Breast Cancer Patients With Bone Dominant Disease

An Open-label Phase IIa, Non-randomized Study of Alpharadin® in Breast Cancer Patients With Bone Dominant Disease no Longer Considered Suitable for Endocrine Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to investigate if multiple (up to four) intravenous injections of Xofigo (Alpharadin) have any clinically relevant effect on bone markers in breast cancer patients with bone dominant disease who have progressed on endocrine therapy and are no longer considered suitable for endocrine therapy. In addition the safety of Xofigo (Alpharadin) will be assessed.

Conditions

• Breast Cancer
• Bone Metastases

Interventions

Type	Name	Description
DRUG	Radium-223 chloride (BAY88-8223)	The required volume of study drug to be administered to a patient was calculated using the patient's body weight (50 kBq/kg b.w.).

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-03-01
• Completion: 2012-01-01
• First posted: 2010-02-18
• Last updated: 2014-06-25

Locations

4 sites across 3 countries: Belgium, Norway, United Kingdom