Comparison of Two Schedules of Zoledronic Acid in Treating Patients With Breast Cancer That Has Spread to the Bone

NCT00458796 | Terminated

• 5 other identifiers: CDR0000538879NCRI-BISMARKISRCTN83586728EU-20716EUDRACT-2005-001376-12
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 30

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.

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

Outcome Measures

Primary Outcomes (5)

• 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

Interventions

zoledronic acid DRUG

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Leeds: lead
• University of Sheffield: collaborator

Study Sites (30)

Royal Bournemouth Hospital

Bournemouth, England, BH7 7DW, United Kingdom

Location

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

Location

Doncaster Royal Infirmary

Doncaster, England, DN2 5LT, United Kingdom

Location

University Hospital of North Durham

Durham, England, DH1 5TW, United Kingdom

Location

Diana Princess of Wales Hospital

Grimsby, England, DN33 2BA, United Kingdom

Location

St. Luke's Cancer Centre at Royal Surrey County Hospital

Guildford, England, GU2 7XX, United Kingdom

Location

Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, HD3 3EA, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, England, L7 8XP, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Withington Hospital

Manchester, England, M20 8LR, United Kingdom

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

George Eliot Hospital

Nuneaton, England, CV10 7DJ, United Kingdom

Location

Dorset Cancer Centre

Poole Dorset, England, BH15 2JB, United Kingdom

Location

Scunthorpe General Hospital

Scunthorpe, England, DN15 7BH, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Royal Shrewsbury Hospital

Shrewsbury, England, SY3 8XQ, United Kingdom

Location

Solihull Hospital

Solihull, England, B91 2JL, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

South Warwickshire Hospital

Warwick, Warwickshire, England, CV34 5BJ, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

Royal Hampshire County Hospital

Winchester, England, SO22 5DG, United Kingdom

Location

Western Infirmary

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Hairmyres Hospital

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Crosshouse Hospital

Kilmarnock, Scotland, KA2 OBE, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Withybush General Hospital

Haverfordwest, Wales, SA61 2PZ, United Kingdom

Location

Royal Gwent Hospital

Newport Gwent, Wales, NP9 2UB, United Kingdom

Location

South West Wales Cancer Institute

Swansea, Wales, SA2 8QA, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Humoral Hypercalcemia Of Malignancy; Neoplasm Metastasis; Pain; Breast Neoplasms, Male

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Robert E. Coleman, MD, FRCP

  Cancer Research Centre at Weston Park Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 9, 2007
• First Posted: April 11, 2007
• Study Start: March 1, 2006
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

GB (30)