CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 44 enrolled
Drug / intervention
Zoledronic acid +1 moredrug
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.

Search/NCT01129336
NCT01129336Phase 4Completed
CompareCT.gov

A Multicenter, Open-label, Randomized Trial to Evaluate the Anti-cancer Effects of Zoledronic Acid and Circulating Tumor Cell Measurements in Patients With HER2-negative Metastatic Breast Cancer Without Bone Metastasis

Novartis Pharmaceuticals·interventional·Posted May 24, 2010·Updated May 20, 2014

In Brief

A Phase 4 clinical trial evaluating Zoledronic acid and Standard Therapy for First or Second Line HER2-negative Breast Cancer and Metastatic Disease Without Bone Metastasis. Completed, enrolled 44 participants across 33 sites.

Detailed Summary

This study will evaluate zoledronic acid's anti-cancer effects and Circulating Tumor Cell (CTCs) measurements in patients with HER2-negative metastatic breast cancer without bone metastasis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFirst or Second Line HER2-negative Breast Cancer, Metastatic Disease Without Bone Metastasis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 24, 2010
Enrollment StartJun 1, 2010
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.1 years ago

Interventions

Zoledronic aciddrug

Patients with no bone metastasis (n=150) will receive Standard therapy plus Zoledronic acid administration 4 mg IV monthly during Months 1-18.

Standard Therapydrug

Standard Therapy, including chemotherapy and hormonal therapy, was determined at the discretion of the investigator.