Breast CancerNCT00458796
Comparison of Two Schedules of Zoledronic Acid in Treating Patients With Breast Cancer That Has Spread to the Bone
A study testing zoledronic acid and quality-of-life assessment in people with Breast Cancer and Hypercalcemia of Malignancy, run by University of Leeds at 30 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer
- What is being tested?
- zoledronic acid and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 30 sitesUnited Kingdom
- Study dates
- Mar 2006to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United Kingdom30 sites
Royal Bournemouth Hospital
Bournemouth, England, BH7 7DW
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
Derbyshire Royal Infirmary
Derby, England, DE1 2QY
Doncaster Royal Infirmary
Doncaster, England, DN2 5LT
University Hospital of North Durham
Durham, England, DH1 5TW
Western Infirmary
Glasgow, Scotland, G11 6NT
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12 0YN
Hairmyres Hospital
Glasgow, Scotland, G12 0YN
Diana Princess of Wales Hospital
Grimsby, England, DN33 2BA
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, GU2 7XX
Withybush General Hospital
Haverfordwest, Wales, SA61 2PZ
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, HD3 3EA
Crosshouse Hospital
Kilmarnock, Scotland, KA2 OBE
Royal Liverpool University Hospital
Liverpool, England, L7 8XP
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Christie Hospital
Manchester, England, M20 4BX
Withington Hospital
Manchester, England, M20 8LR
Clatterbridge Centre for Oncology
Merseyside, England, CH63 4JY
Royal Gwent Hospital
Newport Gwent, Wales, NP9 2UB
George Eliot Hospital
Nuneaton, England, CV10 7DJ
Dorset Cancer Centre
Poole Dorset, England, BH15 2JB
Scunthorpe General Hospital
Scunthorpe, England, DN15 7BH
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S1O 2SJ
Royal Shrewsbury Hospital
Shrewsbury, England, SY3 8XQ
Solihull Hospital
Solihull, England, B91 2JL
Southampton General Hospital
Southampton, England, SO16 6YD
South West Wales Cancer Institute
Swansea, Wales, SA2 8QA
South Warwickshire Hospital
Warwick, Warwickshire, England, CV34 5BJ
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY
Royal Hampshire County Hospital
Winchester, England, SO22 5DG
About this study
Official title: Cost-Effective Use of Bisphosphonates in Metastatic Bone Disease - A Comparison of Bone Marker Directed Zoledronic Acid Therapy to a Standard Schedule
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.
Read the 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^®)] 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.
- Conditions
- Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer, Musculoskeletal Complications, Pain
- Being tested
- zoledronic acid, quality-of-life assessment
- Keywords
- hypercalcemia of malignancy, musculoskeletal complications, pain, stage IV breast cancer, male breast cancer, recurrent breast cancer, bone metastases
- Medical subject headings
- Breast Neoplasms, Humoral Hypercalcemia Of Malignancy, Neoplasm Metastasis, Pain, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acidDrug
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractures
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
Secondary outcomes (8)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startMar 2006
Why it stopped: Lower than expected recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Investigators
- Robert E. Coleman, MD, FRCP, Study chair, Cancer Research Centre at Weston Park Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458796
- Sponsor's protocol ID
- CDR0000538879
- Other IDs
- NCRI-BISMARK, ISRCTN83586728, EU-20716, EUDRACT-2005-001376-12
- Status last verified
- May 2022
- First submitted
- 9 Apr 2007
- Last updated
- 27 May 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Effective Use of Bisphosphonates in Metastatic Bone Disease - A Comparison of Bone Marker Directed Zoledronic Acid Therapy to a Standard Schedule
- ClinicalTrials.gov ID
- NCT00458796
- Acronym / sponsor ID
- CDR0000538879
- Conditions
- Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer, Musculoskeletal Complications, Pain
- Keywords
- hypercalcemia of malignancy, musculoskeletal complications, pain, stage IV breast cancer, male breast cancer, recurrent breast cancer, bone metastases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lower than expected recruitment
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- Mar 2006
- First posted
- 11 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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^®)] 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zoledronic acid | Drug | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Fractures
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
8 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Lower than expected recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert E. Coleman, MD, FRCP study chair
Cancer Research Centre at Weston Park Hospital
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zoledronic acid and quality-of-life assessment in people with Breast Cancer and Hypercalcemia of Malignancy, run by University of Leeds at 30 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lower than expected recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractures. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.