Randomized, Multicentric Phase IV Clinical Trial for the Administration of Pamidronate in Breast Cancer Patients With Bone Metastases

Inclusion Criteria:

- Written informed consent.

- Up to two previous or current hormone therapy treatments for metastatic breast cancer
are allowed.

- Normal or borderline renal function (serum creatinine < 1.5 x upper normal limit
[UNL]).

- Normal calcium levels in serum, or slightly non-symptomatic high levels (< 1.25 x
UNL).

- Performance status 0, I or II in WHO scale.

Exclusion Criteria:

- Treatment with bisphosphonates in the 30 previous days, or any time if the indication
was treatment of metastatic bone lesions.

- Treatment with bisphosphonates is only allowed if the indication is hypercalcaemia.

- Metastases in central nervous system (CNS).

- Hypersensitivity to bisphosphonates or other components of the formula.

- Pregnant or lactating women.

- Previous or current treatment with a second chemotherapy line or a third hormone
therapy line for metastatic disease.