Clinical trial NCT00091832: Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer
Official title: A Randomized Active-controlled Study of AMG 162 in Breast Cancer Subjects With Bone Metastasis Who Have Not Previously Been Treated With Bisphosphonate Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Metastases
Bone Metastases in Subjects With Advanced Breast Cancer
Keywords: Breast Cancer
Cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2004-09-21
Enrollment: 255
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

Primary outcomes:
measure: Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)
timeFrame: Baseline and Week 13
Secondary outcomes:
measure: Percent Change From Baseline to Week 25 in Urinary N-telopeptide (uNTx)
timeFrame: Baseline and Week 25
measure: Number of Participants Achieving 65% or More Reduction in Urinary N-telopeptide (uNTx) From Baseline at Week 13
timeFrame: Baseline and Week 13
measure: Number of Participants Achieving 65% or More Reduction in uNTX From Baseline at Week 25
timeFrame: Baseline and Week 25
measure: Time to 65% or More Reduction in Urinary N-telopeptide (uNTX) From Baseline
timeFrame: Baseline to Week 57
measure: Percent Change From Baseline to Week 13 in Serum C-Telopeptide (CTX)
timeFrame: Baseline and week 13
measure: Percent Change From Baseline to Week 25 in Serum C-telopeptide (CTX)
timeFrame: Baseline and Week 25
measure: Percent Change From Baseline to Week 13 in Procollagen I N-terminal Peptide (P1NP)
timeFrame: Baseline and Week 13
measure: Percent Change From Baseline to Week 25 in P1NP
timeFrame: Baseline and Week 25
measure: Percent Change From Baseline to Week 13 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
timeFrame: Baseline and Week 13
measure: Percent Change From Baseline to Week 25 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
timeFrame: Baseline and Week 25
measure: Percent Change From Baseline to Week 13 in Bone Specific Alkaline Phosphatase (BSAP)
timeFrame: Baseline and Week 13
measure: Percent Change From Baseline to Week 25 in Bone Specific Alkaline Phosphatase (BSAP)
timeFrame: Baseline and Week 25
measure: Percent Change From Baseline to Week 13 in Osteocalcin
timeFrame: Baseline and Week 13
measure: Percent Change From Baseline to Week 25 in Osteocalcin
timeFrame: Baseline and Week 25
measure: Time to First Skeletal Related Event
timeFrame: Day 1 to Week 25
measure: Number of Participants With Skeletal Related Events
timeFrame: From Day 1 to Week 25
measure: Number of Participants With Hypercalcemia
timeFrame: Day 1 to Week 57
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Campbell-Baird C, Lipton A, Sarkenshik M, Ma H, Jun S.Incidence of Acute Phase Events Following Denosumab or Intravenous Bisphosphonates: Results From a Randomized, Controlled Phase 2 Study in Patients With Breast Cancer and Bone Metastases.Journal-001752;2010;7:85-89.
citation: Lipton A, Steger GG, Figueroa J, Alvarado C, Solal-Celigny P, Body JJ, de Boer R, Berardi R, Gascon P, Tonkin KS, Coleman RE, Paterson AH, Gao GM, Kinsey AC, Peterson MC, Jun S. Extended efficacy and safety of denosumab in breast cancer patients with bone metastases not receiving prior bisphosphonate therapy. Clin Cancer Res. 2008 Oct 15;14(20):6690-6. doi: 10.1158/1078-0432.CCR-07-5234.
citation: Lipton A, Steger GG, Figueroa J, Alvarado C, Solal-Celigny P, Body JJ, de Boer R, Berardi R, Gascon P, Tonkin KS, Coleman R, Paterson AH, Peterson MC, Fan M, Kinsey A, Jun S. Randomized active-controlled phase II study of denosumab efficacy and safety in patients with breast cancer-related bone metastases. J Clin Oncol. 2007 Oct 1;25(28):4431-7. doi: 10.1200/JCO.2007.11.8604. Epub 2007 Sep 4.
citation: Peterson M, Rodriquez R., Gurrola E., Sohn W, Jun S (others??).Population pharmacokinetics and pharmacodynamics of denosumab in breast cancer patients with bone metastases.Journal-000709;