Status:
TERMINATED
Comparison of Two Schedules of Zoledronic Acid in Treating Patients With Breast Cancer That Has Spread to the Bone
Lead Sponsor:
University of Leeds
Collaborating Sponsors:
University of Sheffield
Conditions:
Breast Cancer
Hypercalcemia of Malignancy
Eligibility:
All Genders
18-120 years
Phase:
NA
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 randomiz...
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)...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT00458796
Start Date
March 1 2006
Last Update
May 27 2022
Active Locations (30)
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1
Royal Bournemouth Hospital
Bournemouth, England, United Kingdom, BH7 7DW
2
Derbyshire Royal Infirmary
Derby, England, United Kingdom, DE1 2QY
3
Doncaster Royal Infirmary
Doncaster, England, United Kingdom, DN2 5LT
4
University Hospital of North Durham
Durham, England, United Kingdom, DH1 5TW