Multicenter, Open-Label, Randomized Phase III Trial for Administration of Zoledronate to Breast Cancer Metastatic Patients With Non-Symptomatic Bone Lesions
- Written informed consent.
- Age >= 18 years old.
- Metastatic breast cancer patients with lytic, sclerotic or mixed bone lesions.
- Non-symptomatic bone lesions, defined as pain absence, lack of bone complications
(fracture, hypercalcemia, central nervous system [CNS] compression), no need of
analgesic chronic administration for bone disease.
- A maximum of two chemotherapy lines for metastatic disease.
- A maximum of two hormone therapy lines for metastatic disease.
- Normal, minimally altered renal function (serum creatinine < 1.5 x upper normal limit
- Normal serum calcium levels.
- Performance status 0,1 (World Health Organization [WHO]).
- Negative pregnancy test before study recruitment.
- Previous treatment with bisphosphonates or raloxifene in the 30 days prior to
- Metastasis in CNS.
- History of hypersensitivity to bisphosphonates.
- Pregnant or lactating women.
- Third chemotherapy line for metastatic disease.
- Third hormone therapy line for metastatic disease.