check_circleStudy Completed
Breast cancer, Bone Metastases
Bayer Identifier:
15468
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
BAY88-8223, Alpharadin, Breast Cancer pts with bone dominant
Trial purpose
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.
Key Participants Requirements
Sex
FemaleAge
21 - N/ATrial summary
Enrollment Goal
23Trial Dates
January 2010 - January 2012Phase
Phase 2Could I Receive a placebo
NoProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Weston Park Hospital, Cancer Clinical Trials Centre, Academic Unit of Clinical Oncology | Sheffield, United Kingdom |
Completed | Institut Jules Bordet | Brussels, 1000, Belgium |
Completed | Oslo University Hosptial, The Radium Hospital | Oslo, 0310, Norway |
Completed | CHU du Sart Tilman | Liège, 4000, Belgium |
Primary Outcome
- Changes in bone markers (urine levels of NTX (uNTX) and bone-alkaline phosphatase (ALP)date_rangeTime Frame:16 weeksenhanced_encryptionNoSafety Issue:
Secondary Outcome
- All safety data, including adverse events, changes in laboratory variables, vitals signs, physical examination, late toxicitydate_rangeTime Frame:1 yearenhanced_encryptionYesSafety Issue:
- Biochemical markers (additional bone markers and CA15.3)date_rangeTime Frame:16 weeksenhanced_encryptionNoSafety Issue:
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)date_rangeTime Frame:1 yearenhanced_encryptionNoSafety Issue:
- Paindate_rangeTime Frame:1 yearenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1