At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 416 enrolled
Drug / intervention
Zoledronic acid +1 moredrug
Likely dose
Zoledronic acid 4mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Double-blind, Stratified, Multi-center, 2-arm Trial of the Continued Efficacy and Safety of Zoledronic Acid (Every 4 Weeks vs. Every 12 Weeks) in in the 2nd Year of Treatment in Patients With Documented Bone Metastases From Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Zoledronic acid and Placebo for Breast Cancer. Completed, enrolled 416 participants across 92 sites.
Detailed Summary
Clinical trial in breast cancer patients with bone metastases pretreated for approximately 1 year with a standard zoledronic acid regimen. Looking at the continued effectiveness and safety of giving zoledronic acid every 4 weeks versus every 12 weeks given over 1 year. This study is prospective, double-blind, stratified, multi-center, and two-arm.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2006
First PostedMay 2006
Primary CompletionJul 2013
TodayJul 2026
First PostedMay 3, 2006
Enrollment StartFeb 1, 2006
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 20.2 years ago
Interventions
Zoledronic aciddrug
4mg IV
Placebodrug
Placebo to zoledronic acid