Comparison of Two Schedules of Zoledronic Acid in Treating Patients With Breast Cancer That Has Spread to the Bone
Recruitment status was: Recruiting
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.
Hypercalcemia of Malignancy
Drug: zoledronic acid
Procedure: quality-of-life assessment
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Cost-Effective Use of Bisphosphonates in Metastatic Bone Disease - A Comparison of Bone Marker Directed Zoledronic Acid Therapy to a Standard Schedule|
- Radiotherapy to bone either for relief of pain or to treat or prevent pathological fractures or spinal cord compression
- Hypercalcemia of malignancy
- Orthopedic surgery to prevent or treat pathological fractures or spinal cord compression
- Spinal cord compression
- Quality of life as measured by QLQ-C30 and the QLQ-BR23 breast-specific module
- Clinical burden of skeletal complications
- Pain, performance status, and analgesic use
- Incidence of new bone metastases
- Overall survival
- Bisphosphonate use and expenditure on administration
- Health care utilization
- Clinical utility of the "point of care" test for N-telopeptides (NTx) excretion
|Study Start Date:||March 2006|
- Compare the frequency and timing of serious related events (e.g., 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.
- 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-telopeptide:creatinine 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 1,500 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458796
|Royal Bournemouth Hospital|
|Bournemouth, England, United Kingdom, BH7 7DW|
|Derbyshire Royal Infirmary|
|Derby, England, United Kingdom, DE1 2QY|
|Doncaster Royal Infirmary|
|Doncaster, England, United Kingdom, DN2 5LT|
|University Hospital of North Durham|
|Durham, England, United Kingdom, DH1 5TW|
|Diana Princess of Wales Hospital|
|Grimsby, England, United Kingdom, DN33 2BA|
|St. Luke's Cancer Centre at Royal Surrey County Hospital|
|Guildford, England, United Kingdom, GU2 7XX|
|Huddersfield Royal Infirmary|
|Huddersfield, West Yorks, England, United Kingdom, HD3 3EA|
|Royal Liverpool University Hospital|
|Liverpool, England, United Kingdom, L7 8XP|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|Manchester, England, United Kingdom, M20 4BX|
|Manchester, England, United Kingdom, M20 8LR|
|Clatterbridge Centre for Oncology|
|Merseyside, England, United Kingdom, CH63 4JY|
|George Eliot Hospital|
|Nuneaton, England, United Kingdom, CV10 7DJ|
|Dorset Cancer Centre|
|Poole Dorset, England, United Kingdom, BH15 2JB|
|Scunthorpe General Hospital|
|Scunthorpe, England, United Kingdom, DN15 7BH|
|Cancer Research Centre at Weston Park Hospital|
|Sheffield, England, United Kingdom, S1O 2SJ|
|Royal Shrewsbury Hospital|
|Shrewsbury, England, United Kingdom, SY3 8XQ|
|Solihull, England, United Kingdom, B91 2JL|
|Southampton General Hospital|
|Southampton, England, United Kingdom, SO16 6YD|
|South Warwickshire Hospital|
|Warwick, Warwickshire, England, United Kingdom, CV34 5BJ|
|Southend University Hospital NHS Foundation Trust|
|Westcliff-On-Sea, England, United Kingdom, SS0 0RY|
|Royal Hampshire County Hospital|
|Winchester, England, United Kingdom, SO22 5DG|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Beatson West of Scotland Cancer Centre|
|Glasgow, Scotland, United Kingdom, G12 0YN|
|Glasgow, Scotland, United Kingdom, G12 0YN|
|Kilmarnock, Scotland, United Kingdom, KA2 OBE|
|Velindre Cancer Center at Velindre Hospital|
|Cardiff, Wales, United Kingdom, CF14 2TL|
|Withybush General Hospital|
|Haverfordwest, Wales, United Kingdom, SA61 2PZ|
|Royal Gwent Hospital|
|Newport Gwent, Wales, United Kingdom, NP9 2UB|
|South West Wales Cancer Institute|
|Swansea, Wales, United Kingdom, SA2 8QA|
|Study Chair:||Robert E. Coleman, MD, FRCP||Cancer Research Centre at Weston Park Hospital|