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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00458796
Other study ID # CDR0000538879
Secondary ID NCRI-BISMARKISRC
Status Terminated
Phase N/A
First received
Last updated
Start date March 2006

Study information

Verified date May 2022
Source University of Leeds
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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^®)] 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 information / eligibility

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

Study Design


Intervention

Drug:
zoledronic acid

Procedure:
quality-of-life assessment


Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University of Leeds University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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