Phase 2 N=255 Randomized Quadruple-blind Supportive Care

Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer

Breast Cancer · Metastases · Bone Metastases in Subjects With Advanced Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00091832 ↗

Enrolled (actual)

255

Serious AEs

35.4%

Results posted

Jan 2011

Primary outcome: Primary: Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr) — -10.19; -52.87; -54.21; -57.36 Percent change — p=0.245

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Denosumab (Biological); IV Bisphosphonates (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Amgen
Primary completion: Nov 2005

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)	-10.19; -52.87; -54.21; -57.36; -51.73; -18.46	0.245
SECONDARY Percent Change From Baseline to Week 25 in Urinary N-telopeptide (uNTx)	-39.52; -53.46; -43.16; -59.41; -41.79; -39.96	0.848
SECONDARY Number of Participants Achieving 65% or More Reduction in Urinary N-telopeptide (uNTx) From Baseline at Week 13	25; 24; 26; 24; 20; 21	—
SECONDARY Number of Participants Achieving 65% or More Reduction in uNTX From Baseline at Week 25	19; 25; 23; 25; 21; 15	—
SECONDARY Time to 65% or More Reduction in Urinary N-telopeptide (uNTX) From Baseline	10; 13; 11; 10; 9; 30	—
SECONDARY Percent Change From Baseline to Week 13 in Serum C-Telopeptide (CTX)	-66.92; -80.76; -78.45; -81.79; -70.50; -78.13	—
SECONDARY Percent Change From Baseline to Week 25 in Serum C-telopeptide (CTX)	-73.09; -82.70; -74.48; -80.07; -70.64; -78.31	—
SECONDARY Percent Change From Baseline to Week 13 in Procollagen I N-terminal Peptide (P1NP)	-50.75; -52.35; -48.23; -50.47; -43.94; -59.42	—
SECONDARY Percent Change From Baseline to Week 25 in P1NP	-50.48; -53.48; -55.90; -57.88; -51.18; -51.37	—
SECONDARY Percent Change From Baseline to Week 13 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)	-37.45; -56.07; -58.24; -53.12; -55.85; -55.91	—
SECONDARY Percent Change From Baseline to Week 25 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)	-38.59; -58.58; -52.39; -51.15; -56.25; -53.13	—
SECONDARY Percent Change From Baseline to Week 13 in Bone Specific Alkaline Phosphatase (BSAP)	-40.01; 26.37; -40.23; -38.42; -37.11; -35.94	—
SECONDARY Percent Change From Baseline to Week 25 in Bone Specific Alkaline Phosphatase (BSAP)	-46.56; 15.88; -49.01; -52.60; -46.72; -48.24	—
SECONDARY Percent Change From Baseline to Week 13 in Osteocalcin	6.82; -19.35; -2.39; -6.23; -23.78; -5.96	—
SECONDARY Percent Change From Baseline to Week 25 in Osteocalcin	-4.74; -30.78; -22.80; -26.95; -23.93; -22.69	—
SECONDARY Time to First Skeletal Related Event	NA; NA; NA; NA; NA; NA	—
SECONDARY Number of Participants With Skeletal Related Events	7; 4; 8; 6; 4; 4	—
SECONDARY Number of Participants With Hypercalcemia	0; 0; 0; 0; 0; 0	—

Summary

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

Eligibility Criteria

Inclusion Criteria: - Histologically or cytologically confirmed breast adenocarcinoma

At least one bone metastasis

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00091832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.