Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-Symptomatic Bone Lesions
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.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter, Open-Label, Randomized Phase III Trial for Administration of Zoledronate to Breast Cancer Metastatic Patients With Non-Symptomatic Bone Lesions|
|Spanish Breast Cancer Research Group (GEICAM)|
|San Sebastián de los Reyes, Madrid, Spain, 28700|
|Study Chair:||Agustí Barnadas, MD.,PhD||Spanish Breast Cancer Research Group (GEICAM)|
|Study Chair:||Ana Lluch, MD.,PhD.||Spanish Breast Cancer Research Group (GEICAM)|