Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:00 AM
Study NCT ID:
NCT00130494
Status:
TERMINATED
Last Update Posted:
2019-04-16
First Post:
2005-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions
Sponsor:
Spanish Breast Cancer Research Group
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: