Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-Symptomatic Bone Lesions
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|ClinicalTrials.gov Identifier: NCT00130494|
Recruitment Status : Terminated
First Posted : August 15, 2005
Last Update Posted : February 7, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Neoplasm Metastasis||Drug: Zoledronic acid||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||224 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Open-Label, Randomized Phase III Trial for Administration of Zoledronate to Breast Cancer Metastatic Patients With Non-Symptomatic Bone Lesions|
|Study Start Date :||August 2002|
|Study Completion Date :||December 2006|
- Time to first bone metastases symptom
- Quality of life
- Safety profile
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00130494
|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)|