Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00458796
Status:
TERMINATED
Last Update Posted:
2022-05-27
First Post:
2007-04-09
Brief Title:
Comparison of Two Schedules of Zoledronic Acid in Treating Patients With Breast Cancer That Has Spread to the Bone
Sponsor:
University of Leeds
Organization:
University of Leeds
Study Overview
Official Title:
Cost-Effective Use of Bisphosphonates in Metastatic Bone Disease - A Comparison of Bone Marker Directed Zoledronic Acid Therapy to a Standard Schedule
Status:
TERMINATED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lower than expected recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Zoledronic acid may help decrease the risk of broken bones bone pain and other symptoms caused by bone metastases It may also help patients live more comfortably
PURPOSE This randomized clinical trial is studying different schedules of zoledronic acid to compare how well they work in treating patients with breast cancer that has spread to the bone
PURPOSE This randomized clinical trial is studying different schedules of zoledronic acid to compare how well they work in treating patients with breast cancer that has spread to the bone
Detailed Description:
OBJECTIVES
Primary
Compare the frequency and timing of serious related events eg fractures radiotherapy to bone hypercalcemia of malignancy orthopedic surgery and spinal cord compression in patients with advanced breast cancer metastatic to the bone treated with bone marker-directed schedule vs standard schedule zoledronic acid
Secondary
Compare the quality of life of patients treated with these regimens
Compare the clinical burden of skeletal complications in these patients
Compare pain performance status and analgesic use PPA score in these patients
Compare the incidence of new bone metastases in these patients
Compare overall survival of these patients
Compare bisphosphonate use and expenditure on administration in these patients
OUTLINE This is an open-label randomized controlled parallel-group multicenter study Patients are stratified according to treatment center gender type of concurrent systemic therapy at study entry endocrine therapy with or without trastuzumab Herceptin vs chemotherapy with or without trastuzumab vs trastuzumab alone vs chemotherapy and endocrine therapy with or without trastuzumab vs no systemic anticancer treatment prior skeletal-related event yes vs no duration of bisphosphonate use for metastatic disease prior to study entry 4-6 months vs 6-12 months type of metastases present at study entry bone only vs bone and soft tissue vs bone and visceral metastases vs bone soft tissue and visceral metastases Patients are randomized to 1 of 2 treatment arms
Arm I standard schedule Patients receive zoledronic acid IV over 15 minutes once every 3-4 weeks for 24 months
Arm II bone marker-directed schedule Patients receive zoledronic acid IV over 15 minutes once every 3-4 8-9 or 15-16 weeks based on serum N-telopeptidecreatinine ratio for 24 months
Quality of life is assessed at baseline and at 3 6 9 12 18 and 24 months
After completion of study therapy patients are followed periodically for up to 3 years
PROJECTED ACCRUAL A total of 1500 patients will be accrued for this study
Primary
Compare the frequency and timing of serious related events eg fractures radiotherapy to bone hypercalcemia of malignancy orthopedic surgery and spinal cord compression in patients with advanced breast cancer metastatic to the bone treated with bone marker-directed schedule vs standard schedule zoledronic acid
Secondary
Compare the quality of life of patients treated with these regimens
Compare the clinical burden of skeletal complications in these patients
Compare pain performance status and analgesic use PPA score in these patients
Compare the incidence of new bone metastases in these patients
Compare overall survival of these patients
Compare bisphosphonate use and expenditure on administration in these patients
OUTLINE This is an open-label randomized controlled parallel-group multicenter study Patients are stratified according to treatment center gender type of concurrent systemic therapy at study entry endocrine therapy with or without trastuzumab Herceptin vs chemotherapy with or without trastuzumab vs trastuzumab alone vs chemotherapy and endocrine therapy with or without trastuzumab vs no systemic anticancer treatment prior skeletal-related event yes vs no duration of bisphosphonate use for metastatic disease prior to study entry 4-6 months vs 6-12 months type of metastases present at study entry bone only vs bone and soft tissue vs bone and visceral metastases vs bone soft tissue and visceral metastases Patients are randomized to 1 of 2 treatment arms
Arm I standard schedule Patients receive zoledronic acid IV over 15 minutes once every 3-4 weeks for 24 months
Arm II bone marker-directed schedule Patients receive zoledronic acid IV over 15 minutes once every 3-4 8-9 or 15-16 weeks based on serum N-telopeptidecreatinine ratio for 24 months
Quality of life is assessed at baseline and at 3 6 9 12 18 and 24 months
After completion of study therapy patients are followed periodically for up to 3 years
PROJECTED ACCRUAL A total of 1500 patients will be accrued for this study
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT-2005-001376-12 | None | None | None |
| NCRI-BISMARK | None | None | None |
| ISRCTN83586728 | None | None | None |
| EU-20716 | None | None | None |