Status:
UNKNOWN
Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast Cancer
Lead Sponsor:
Wales Cancer Trials Unit
Collaborating Sponsors:
Velindre NHS Trust
Conditions:
Breast Cancer
Hypercalcemia of Malignancy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Ibandronate and zoledronate may help relieve some of the symptoms caused by bone metastases. It is not yet know whether ibandronate is more effective than zoledronate in treating bone metas...
Detailed Description
OBJECTIVES: Primary * Compare the efficacy, in terms of reducing frequency and timing of skeletal-related events (SREs), of ibandronate vs zoledronate in patients with newly diagnosed bone metastase...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically proven breast cancer
- Metastatic disease
- Previous relapsed disease in sites other than bone allowed
- Newly diagnosed multiple bone metastases within the past 3 months, meeting all of the following criteria:
- Painful or asymptomatic
- Lytic, mixed, or purely sclerotic type
- Radiological diagnosis
- IV bisphosphonate therapy indicated
- No CNS metastases
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Male or female
- Menopausal status not specified
- No known active peptic ulcer
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No active dental problems, including infection of the teeth or jawbone (maxilla or mandible) or dental or fixture trauma
- No prior or current diagnosis of osteonecrosis of the jaw, exposed bone in the mouth, or slow healing after dental procedures
- Creatinine clearance ≥ 30 mL/min
- Bilirubin ≤ 1.5 x upper limit of normal (ULN)
- AST and ALT ≤ 1.5 times ULN
- No history of bisphosphonate hypersensitivity
- Able to comply with instructions relating to oral study medications
- Able to take oral study medications
- No psychiatric illness or other condition that would preclude giving informed consent
- PRIOR CONCURRENT THERAPY:
- At least 6 months since prior bisphosphonate therapy
- At least 6 weeks since prior and no concurrent dental or jaw surgery (e.g., extractions or implants)
- Concurrent unplanned dental extractions allowed provided study medication is discontinued for 8 weeks before and after the surgery
- Concurrent chemotherapy and/or hormone therapy for metastatic disease allowed
- No concurrent medications that affect bone metabolism (e.g., calcitonin or other nontrial bisphosphonates)
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
1404 Patients enrolled
Trial Details
Trial ID
NCT00326820
Start Date
January 1 2006
End Date
October 1 2015
Last Update
March 13 2013
Active Locations (79)
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1
William Harvey Hospital
Ashford, England, United Kingdom, TN24 0LZ
2
North Devon District Hospital
Barnstaple, England, United Kingdom, EX31 4JB
3
Royal Bournemouth Hospital
Bournemouth, England, United Kingdom, BH7 7DW
4
Burnley General Hospital
Burnley, England, United Kingdom, BB10 2PQ