Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130494
Status:
TERMINATED
Last Update Posted:
2019-04-16
First Post:
2005-08-12
Brief Title:
Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Spanish Breast Cancer Research Group
Study Overview
Official Title:
Multicenter Open-label Randomized Phase III Trial for Administration of Zoledronate to Breast Cancer Metastatic Patients With Non-symptomatic Bone Lesions
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None