Inclusion Criteria

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)