CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 255 enrolled
Drug / intervention
Denosumab +1 morebiological
Likely dose
Denosumab administered by subcutaneous injection; IV bisphosphonates (pamidronate, ibandronic acid, zoledronic acid) per package insertAI-extracted
Key inclusion· 2
  • ✓Histologically or cytologically confirmed breast adenocarcinoma
  • ✓At least one bone metastasis
Key exclusion· 0

None specified.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00091832
NCT00091832Phase 2Completed
CompareCT.gov

A Randomized Active-controlled Study of AMG 162 in Breast Cancer Subjects With Bone Metastasis Who Have Not Previously Been Treated With Bisphosphonate Therapy.

Amgen·interventional·Posted Sep 21, 2004·Updated Jan 28, 2014

In Brief

A Phase 2 clinical trial evaluating Denosumab and IV Bisphosphonates for Breast Cancer and 2 related conditions. Completed, enrolled 255 participants.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Metastases, Bone Metastases in Subjects With Advanced Breast Cancer
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2004
Enrollment StartSep 1, 2004
Primary CompletionNov 1, 2005
Study CompletionOct 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 21.8 years ago

Interventions

Denosumabbiological

Denosumab administered by subcutaneous injection

IV Bisphosphonatesdrug

Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid