Spots Global Cancer Trial Database for Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions

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Trial Identification

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

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

Study ID: NCT00130494

Conditions

Breast Cancer

Neoplasm Metastasis

Interventions

Zoledronic acid

Study Description

Brief 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.