A Randomized Active-controlled Study of AMG 162 in Breast Cancer Subjects With Bone Metastasis Who Have Not Previously Been Treated With Bisphosphonate Therapy.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 255
- Primary Endpoint
- Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)
Study Overview
Brief Summary
This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically or cytologically confirmed breast adenocarcinoma
- •At least one bone metastasis
Exclusion Criteria
- Not provided
Arms & Interventions
Denosumab 60 mg every 12 weeks
Denosumab 60 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks.
Intervention: Denosumab (Biological)
Denosumab 120 mg every 4 weeks
Denosumab 120 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.
Intervention: Denosumab (Biological)
Denosumab 180 mg every 4 weeks
Denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.
Intervention: Denosumab (Biological)
IV bisphosphonates every 4 weeks
Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion for 25 weeks.
Intervention: IV Bisphosphonates (Drug)
Denosumab 180 mg every 12 weeks
Denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks.
Intervention: Denosumab (Biological)
Denosumab 30 mg every 4 weeks
Denosumab 30 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.
Intervention: Denosumab (Biological)
Outcomes
Primary Outcomes
Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)
Time Frame: Baseline and Week 13
Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.
Secondary Outcomes
- Number of Participants Achieving 65% or More Reduction in Urinary N-telopeptide (uNTx) From Baseline at Week 13(Baseline and Week 13)
- Percent Change From Baseline to Week 25 in Urinary N-telopeptide (uNTx)(Baseline and Week 25)
- Number of Participants Achieving 65% or More Reduction in uNTX From Baseline at Week 25(Baseline and Week 25)
- Time to 65% or More Reduction in Urinary N-telopeptide (uNTX) From Baseline(Baseline to Week 57)
- Percent Change From Baseline to Week 13 in Serum C-Telopeptide (CTX)(Baseline and week 13)
- Percent Change From Baseline to Week 25 in Serum C-telopeptide (CTX)(Baseline and Week 25)
- Percent Change From Baseline to Week 13 in Procollagen I N-terminal Peptide (P1NP)(Baseline and Week 13)
- Percent Change From Baseline to Week 25 in P1NP(Baseline and Week 25)
- Percent Change From Baseline to Week 13 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)(Baseline and Week 13)
- Percent Change From Baseline to Week 25 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)(Baseline and Week 25)
- Percent Change From Baseline to Week 13 in Bone Specific Alkaline Phosphatase (BSAP)(Baseline and Week 13)
- Percent Change From Baseline to Week 25 in Bone Specific Alkaline Phosphatase (BSAP)(Baseline and Week 25)
- Percent Change From Baseline to Week 13 in Osteocalcin(Baseline and Week 13)
- Percent Change From Baseline to Week 25 in Osteocalcin(Baseline and Week 25)
- Time to First Skeletal Related Event(Day 1 to Week 25)
- Number of Participants With Skeletal Related Events(From Day 1 to Week 25)
- Number of Participants With Hypercalcemia(Day 1 to Week 57)