Efficacy and Tolerability of Intravenous Zoledronic Acid 4mg as an Adjunct to Standard Therapies Including Conversion From Pamidronate in Breast Cancer Patients With Metastatic Bone Lesions. A Prospective, Randomised, Open-label, Clinical Study

Novartis1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2002年8月1日最近更新: 2009年11月23日

适应症

试验速览

阶段: 3 期
状态: 终止
发起方: Novartis
入组人数: 30
试验地点: 1
主要终点: 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

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Confirmed diagnosis of Breast Cancer with at least one breast cancer-related bone lesion
•No treatment with bisphosphonates within 6 months prior to inclusion into the study
•Good health status (ECOG Performance status 0-2)

排除标准

•Patients who do not have at least one breast cancer-related bone lesion that is detectable on conventional radiographs of bone (plain film) at screening
•Abnormal renal function
•History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism
•Pregnancy and lactation
•Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures, recent (within 6 weeks) or planned dental or jaw surgery (e.g..extraction, implants)

结局指标

主要结局

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

次要结局

Comparison of the safety, tolerability, and efficacy in the treatment arms

研究者

发起方

Novartis

申办方类型

Industry

研究点 (1)

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