Breast Cancer Clinical Trial
Official title:
Cost-Effective Use of Bisphosphonates in Metastatic Bone Disease - A Comparison of Bone Marker Directed Zoledronic Acid Therapy to a Standard Schedule
NCT number | NCT00458796 |
Other study ID # | CDR0000538879 |
Secondary ID | NCRI-BISMARKISRC |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2006 |
Verified date | May 2022 |
Source | University of Leeds |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1500 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | DISEASE CHARACTERISTICS: - Histologically confirmed primary breast cancer - Advanced disease - Radiographic confirmation of bone metastases (= 1 bone scan lesion must be confirmed as metastatic by plain radiographs or CT scan/MRI) - Must have received zoledronic acid to treat metastatic bone disease (i.e., = 4 or 5 zoledronic acid treatments prior to study entry for patients receiving 4- or 3-weekly infusions, respectively) for = 4 months prior to study entry - Any bisphosphonate to treat metastatic bone disease allowed provided it was not given for more than 12 months prior to study entry - No metabolic bone disease (e.g., Paget's disease of bone) - Osteoporosis allowed - No brain metastases - Hormone receptor status not specified PATIENT CHARACTERISTICS: - Male or female - Menopausal status not specified - WHO or ECOG performance status 0-2 - Life expectancy = 6 months - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - AST and ALT = 3 times upper limit of normal (ULN) - Bilirubin = 1.5 times ULN - Creatinine clearance = 30 mL/min - No poor venous access - No concurrent active dental problems, including infection of the teeth or jawbone (maxilla or mandibular) - No prior or current diagnosis of osteonecrosis of the jaw - No other cancer within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of the uterine cervix, or superficial bladder cancer treated with curative intent PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No other prior bisphosphonate treatment within the past 3 weeks - No treatment with systemic bone-seeking radioisotopes (e.g., strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium) within the past 3 months - No wide-field (hemibody) radiotherapy within the past 3 months - Recent standard-field, localized radiotherapy allowed - No dental or jaw surgery (e.g., extractions, implants) within the past 4 weeks - No other concurrent bisphosphonates - No concurrent medication with drugs known to affect bone metabolism (e.g., calcitonin or high-dose systemic corticosteroids [> 10 mg prednisolone/day or equivalent]) - Systemic or oral corticosteroids allowed for clearly indicated conditions (e.g., chemotherapy-induced emesis, brain metastases, compression syndromes) - Concurrent chemotherapy, biological therapy, or endocrine therapy allowed |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Bournemouth Hospital | Bournemouth | England |
United Kingdom | Velindre Cancer Center at Velindre Hospital | Cardiff | Wales |
United Kingdom | Derbyshire Royal Infirmary | Derby | England |
United Kingdom | Doncaster Royal Infirmary | Doncaster | England |
United Kingdom | University Hospital of North Durham | Durham | England |
United Kingdom | Beatson West of Scotland Cancer Centre | Glasgow | Scotland |
United Kingdom | Hairmyres Hospital | Glasgow | Scotland |
United Kingdom | Western Infirmary | Glasgow | Scotland |
United Kingdom | Diana Princess of Wales Hospital | Grimsby | England |
United Kingdom | St. Luke's Cancer Centre at Royal Surrey County Hospital | Guildford | England |
United Kingdom | Withybush General Hospital | Haverfordwest | Wales |
United Kingdom | Huddersfield Royal Infirmary | Huddersfield, West Yorks | England |
United Kingdom | Crosshouse Hospital | Kilmarnock | Scotland |
United Kingdom | Royal Liverpool University Hospital | Liverpool | England |
United Kingdom | Saint Bartholomew's Hospital | London | England |
United Kingdom | Christie Hospital | Manchester | England |
United Kingdom | Withington Hospital | Manchester | England |
United Kingdom | Clatterbridge Centre for Oncology | Merseyside | England |
United Kingdom | Royal Gwent Hospital | Newport Gwent | Wales |
United Kingdom | George Eliot Hospital | Nuneaton | England |
United Kingdom | Dorset Cancer Centre | Poole Dorset | England |
United Kingdom | Scunthorpe General Hospital | Scunthorpe | England |
United Kingdom | Cancer Research Centre at Weston Park Hospital | Sheffield | England |
United Kingdom | Royal Shrewsbury Hospital | Shrewsbury | England |
United Kingdom | Solihull Hospital | Solihull | England |
United Kingdom | Southampton General Hospital | Southampton | England |
United Kingdom | South West Wales Cancer Institute | Swansea | Wales |
United Kingdom | South Warwickshire Hospital | Warwick, Warwickshire | England |
United Kingdom | Southend University Hospital NHS Foundation Trust | Westcliff-On-Sea | England |
United Kingdom | Royal Hampshire County Hospital | Winchester | England |
Lead Sponsor | Collaborator |
---|---|
University of Leeds | University of Sheffield |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fractures | |||
Primary | Radiotherapy to bone either for relief of pain or to treat or prevent pathological fractures or spinal cord compression | |||
Primary | Hypercalcemia of malignancy | |||
Primary | Orthopedic surgery to prevent or treat pathological fractures or spinal cord compression | |||
Primary | Spinal cord compression | |||
Secondary | Quality of life as measured by QLQ-C30 and the QLQ-BR23 breast-specific module | |||
Secondary | Clinical burden of skeletal complications | |||
Secondary | Pain, performance status, and analgesic use | |||
Secondary | Incidence of new bone metastases | |||
Secondary | Overall survival | |||
Secondary | Bisphosphonate use and expenditure on administration | |||
Secondary | Health care utilization | |||
Secondary | Clinical utility of the "point of care" test for N-telopeptides (NTx) excretion |
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