Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions
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|ClinicalTrials.gov Identifier: NCT00130494|
Recruitment Status : Terminated (Low recruitment)
First Posted : August 15, 2005
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Neoplasm Metastasis||Drug: Zoledronic acid||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 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|
|Actual Study Start Date :||August 29, 2002|
|Actual Primary Completion Date :||November 20, 2006|
|Actual Study Completion Date :||October 22, 2007|
Experimental: Arm A: Zoledronic acid 4 mg
Zoledronate 4 mg every 3 or 4 weeks. This arm will receive study treatment from the time of entry into the trial, until the appearance of the symptoms of bone metastases (or a maximum period of 12 months, whichever occurs first).
Drug: Zoledronic acid
Other Name: Zometa
No Intervention: Arm B: Observation
Patients will not receive any treatment with bisphosphonates until the time of onset of symptoms (or a maximum period of 12 months, whichever occurs sooner).
- Time to first bone metastases [ Time Frame: Up to disease progression ]The main variable of evaluation is the time until the appearance of first bone metastases.
- Quality of life per treatment arm [ Time Frame: Up to disease progression ]Quality of Life (QoL) will be measured with Short Form (SF)-36 questionnaire and Short questionnaire for the evaluation of pain since baseline visit and during all treatment period delivered to the patient before the start of each visit.
- The Number of Participants Who Experienced Adverse Events (AE) [ Time Frame: Through study treatment ]Safety will be assessed by standard clinical and laboratory tests. Adverse events grade will be defined by the NCI CTCAE.
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 Director:||Study Director||Hospital Clínico Universitario de Valencia|
|Study Director:||Study Director||Hospital Santa Creu i Sant Pau|