At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 430 enrolled
Drug / intervention
Zoledronic aciddrug
Likely dose
Zoledronic acid 4 mgfrom 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, Multi-center Comparative 2-arm Trial of Efficacy and Safety of Zoledronic Acid (Every 3-months vs. Every 4 Weeks) Beyond Approximately 1 Year of Treatment With Zoledronic Acid in Patients With Bone Lesions From Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Zoledronic acid for Breast Cancer With Bone Metastasis. Completed, enrolled 430 participants across 1 site.
Detailed Summary
The objective of this study is to assess the clinical benefit of two different dosing schedules of zoledronic acid in patients with metastatic bone lesions from breast cancer who have already been treated with zoledronic acid for about one year.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer With Bone Metastasis
CountriesItaly
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2006
First PostedSep 2006
Primary CompletionFeb 2010
TodayJul 2026
First PostedSep 13, 2006
Enrollment StartFeb 1, 2006
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 19.8 years ago
Interventions
Zoledronic aciddrug
Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion. The dose of study drug will be the same administered before the study entry, that is 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg.