Safety/Efficacy of Intravenous Zoledronic Acid When Added to Standard Therapies in Patients With Breast Cancer and Metastatic Bone Lesions
Safety/Efficacy of Intravenous Zoledronic Acid When Added to Standard Therapies in Patients With Breast Cancer and Metastatic Bone Lesions
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 breast cancer patients with metastatic bone lesions.
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)