Clinical trial · Interventional
Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer
A Randomized Active-controlled Study of AMG 162 in Breast Cancer Subjects With Bone Metastasis Who Have Not Previously Been Treated With Bisphosphonate Therapy.
NCT00091832CI-TRIAL-00013581completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases in Subjects With Advanced Breast Cancer | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Denosumab | Biological | Denosumab | ALIAS |
| IV Bisphosphonates | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Denosumab 60 mg every 12 weeks
- description
- Denosumab 60 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks.
- interventionNames
- Biological: Denosumab
- type
- EXPERIMENTAL
- label
- Denosumab 120 mg every 4 weeks
- description
- Denosumab 120 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.
- interventionNames
- Biological: Denosumab
- type
- EXPERIMENTAL
- label
- Denosumab 180 mg every 4 weeks
- description
- Denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: - Histologically or cytologically confirmed breast adenocarcinoma * At least one bone metastasis
References
Publications (4)
- BACKGROUNDCampbell-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.
- BACKGROUNDLipton 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. PMID 18927312
- BACKGROUNDLipton 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. PMID 17785705
- BACKGROUNDPeterson 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;