Status:
TERMINATED
Safety/Efficacy of Intravenous Zoledronic Acid When Added to Standard Therapies in Patients With Breast Cancer and Metastatic Bone Lesions
Lead Sponsor:
Novartis
Conditions:
Breast Cancer With Bone Metastasis
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Zoledronic acid selectively binds to bone and protects it from being metastasized by tumor cells. This study evaluates the safety and efficacy of zoledronic acid when added to standard therapies in br...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Confirmed diagnosis of Breast Cancer with at least one breast cancer-related bone lesion
- No treatment with bisphosphonates within 6 months prior to inclusion into the study
- Good health status (ECOG Performance status 0-2)
- Exclusion criteria
- Patients who do not have at least one breast cancer-related bone lesion that is detectable on conventional radiographs of bone (plain film) at screening
- Abnormal renal function
- History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism
- Pregnancy and lactation
- Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures, recent (within 6 weeks) or planned dental or jaw surgery (e.g..extraction, implants)
Exclusion
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00372710
Start Date
August 1 2002
Last Update
November 23 2009
Active Locations (1)
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1
Freiburg im Breisgau, Germany