Trial intelligence / Profile preview

ZICE: Ibandronate vs Zoledronate in Breast Cancer with Bone Metastases

NCT00326820Phase 3

Key facts

Status: Unknown
Start: Jan 2006
Primary completion: Dec 2012
Countries: 1
Sponsor: Wales Cancer Trials Unit
Modality: Small Molecules

Drugs: ibandronate
Conditions: breast cancerbone metastases

Overview

Phase 3, randomised, open-label trial of ibandronate in breast cancer and bone metastases (2 arms), sponsored by Wales Cancer Trials Unit. Primary endpoint: Frequency and timing of skeletal-related events at 96 weeks. Status: unknown.

Design

2 arms

Study design: RandomizedOpen-label

Zoledronic Acid
Intravenous zoledronate 4mg every 3-4 weeks for 96 weeks.
Ibandronic Acid
Oral ibandronate 50mg daily for 96 weeks.

Who it enrols

Patients with histologically proven metastatic breast cancer and newly diagnosed bone metastases, with adequate renal and hepatic function and no prior bisphosphonate use within 6 months.

Endpoints

Primary

Frequency and timing of skeletal-related events96 weeks

Secondary

Median time to first skeletal-related event96 weeks
Percentage of patients experiencing a skeletal-related event96 weeks
Number of occult vertebral fracturesend of treatment
Pain score96 weeks
Analgesic score96 weeks
Quality of life96 weeks
Number of patients developing renal dysfunction96 weeks
Number of patients developing hypocalcemia96 weeks

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