Randomized, Multicentric Phase IV Clinical Trial for the Administration of Pamidronate in Breast Cancer Patients With Bone Metastases
- Written informed consent.
- Up to two previous or current hormone therapy treatments for metastatic breast cancer
- Normal or borderline renal function (serum creatinine < 1.5 x upper normal limit
- Normal calcium levels in serum, or slightly non-symptomatic high levels (< 1.25 x
- Performance status 0, I or II in WHO scale.
- 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.