Safety/Efficacy of Intravenous Zoledronic Acid When Added to Standard Therapies in Patients With Breast Cancer and Metastatic Bone Lesions

Phase 3

Terminated

• Conditions: Breast Cancer With Bone Metastasis

• Registration Number: NCT00372710
• Lead Sponsor: Novartis

Brief Summary

Zoledronic acid selectively binds to bone and protects it from being metastasized by tumor cells. This study evaluates the safety and efficacy of zoledronic acid when added to standard therapies in breast cancer patients with metastatic bone lesions.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2006-09-06
• Study First Submitted QC: 2006-09-06
• Study First Posted: 2006-09-07
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-20
• Last Update Posted: 2009-11-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy of a switch over from pamidronate therapy (2 infusions) to a treatment with zoledronic acid 4mg every 4 weeks (10 infusions) for 44 weeks in patients with breast cancer-related bone lesions

Secondary Outcome Measures

Name	Time	Method
Comparison of the safety, tolerability, and efficacy in the treatment arms