NCT00130494

Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions

Multicenter, Open-label, Randomized Phase III Trial for Administration of Zoledronate to Breast Cancer Metastatic Patients With Non-symptomatic Bone Lesions

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Spanish Breast Cancer Research Group · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, randomized, multicenter phase III trial to assess the efficacy of early administration of zoledronate versus observation in delaying bone-related symptoms in metastatic breast cancer patients.

Detailed description

Patients will be randomised to receive 4 mg zoledronate every 3-4 weeks versus observation until bone-related symptoms appear, or up to 12 months. One hundred twelve patients per treatment arm will be enrolled in the study. Once bone-related symptoms appear, study participation is over. During the study, the following will be assessed: * quality of life, * performance status, * pain rating, * analgesic administration and * adverse events The principal objective is the delay in bone-related symptoms in those patients with early zoledronate administration.

Conditions

• Breast Cancer
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	Zoledronic acid

Timeline

• Start date: 2002-08-29
• Primary completion: 2006-11-20
• Completion: 2007-10-22
• First posted: 2005-08-15
• Last updated: 2019-04-16

Locations

1 site across 1 country: Spain