Comparison of Two Schedules of Zoledronic Acid in Treating Patients With Breast Cancer That Has Spread to the Bone
- Conditions
- Breast CancerHypercalcemia of MalignancyMetastatic CancerMusculoskeletal ComplicationsPain
- Registration Number
- NCT00458796
- Lead Sponsor
- University of Leeds
- 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.
- Detailed Description
OBJECTIVES:
Primary
* 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.
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 \[with or without trastuzumab (Herceptin\^ยฎ)\] 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hypercalcemia of malignancy Fractures Radiotherapy to bone either for relief of pain or to treat or prevent pathological fractures or spinal cord compression Orthopedic surgery to prevent or treat pathological fractures or spinal cord compression Spinal cord compression
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (30)
Western Infirmary
๐ฌ๐งGlasgow, Scotland, United Kingdom
Beatson West of Scotland Cancer Centre
๐ฌ๐งGlasgow, Scotland, United Kingdom
Withybush General Hospital
๐ฌ๐งHaverfordwest, Wales, United Kingdom
Royal Bournemouth Hospital
๐ฌ๐งBournemouth, England, United Kingdom
Derbyshire Royal Infirmary
๐ฌ๐งDerby, England, United Kingdom
Doncaster Royal Infirmary
๐ฌ๐งDoncaster, England, United Kingdom
University Hospital of North Durham
๐ฌ๐งDurham, England, United Kingdom
Christie Hospital
๐ฌ๐งManchester, England, United Kingdom
Huddersfield Royal Infirmary
๐ฌ๐งHuddersfield, West Yorks, England, United Kingdom
Saint Bartholomew's Hospital
๐ฌ๐งLondon, England, United Kingdom
Withington Hospital
๐ฌ๐งManchester, England, United Kingdom
Clatterbridge Centre for Oncology
๐ฌ๐งMerseyside, England, United Kingdom
Dorset Cancer Centre
๐ฌ๐งPoole Dorset, England, United Kingdom
George Eliot Hospital
๐ฌ๐งNuneaton, England, United Kingdom
Scunthorpe General Hospital
๐ฌ๐งScunthorpe, England, United Kingdom
Southampton General Hospital
๐ฌ๐งSouthampton, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
๐ฌ๐งSheffield, England, United Kingdom
Solihull Hospital
๐ฌ๐งSolihull, England, United Kingdom
South Warwickshire Hospital
๐ฌ๐งWarwick, Warwickshire, England, United Kingdom
Southend University Hospital NHS Foundation Trust
๐ฌ๐งWestcliff-On-Sea, England, United Kingdom
Hairmyres Hospital
๐ฌ๐งGlasgow, Scotland, United Kingdom
Diana Princess of Wales Hospital
๐ฌ๐งGrimsby, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
๐ฌ๐งGuildford, England, United Kingdom
Royal Shrewsbury Hospital
๐ฌ๐งShrewsbury, England, United Kingdom
Royal Hampshire County Hospital
๐ฌ๐งWinchester, England, United Kingdom
Crosshouse Hospital
๐ฌ๐งKilmarnock, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
๐ฌ๐งCardiff, Wales, United Kingdom
Royal Gwent Hospital
๐ฌ๐งNewport Gwent, Wales, United Kingdom
South West Wales Cancer Institute
๐ฌ๐งSwansea, Wales, United Kingdom
Royal Liverpool University Hospital
๐ฌ๐งLiverpool, England, United Kingdom