Conditions: Breast Cancer Metastases Bone Metastases in Subjects With Advanced Breast Cancer
Keywords: Breast Cancer Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 255
Healthy volunteers: no

Brief summary:
This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.

Detailed description:

Arms:
arm 1: Denosumab 60 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks. arm 2: Denosumab 120 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks. arm 3: Denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks. arm 4: Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion for 25 weeks. arm 5: Denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks. arm 6: Denosumab 30 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.

Interventions: intervention 1: Denosumab intervention 2: IV Bisphosphonates
Intervention descriptions: intervention 1: Denosumab administered by subcutaneous injection intervention 2: Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid

Protocol document: