Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions
Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions
This is an open-label, randomized, multicenter phase III trial to assess the efficacy of
 early administration of zoledronate versus observation in delaying bone-related symptoms in
 metastatic breast cancer patients.
Patients will be randomised to receive 4 mg zoledronate every 3-4 weeks versus observation
 until bone-related symptoms appear, or up to 12 months. One hundred twelve patients per
 treatment arm will be enrolled in the study.

 Once bone-related symptoms appear, study participation is over. During the study, the
 following will be assessed:

 -  quality of life,

 -  performance status,

 -  pain rating,

 -  analgesic administration and

 -  adverse events The principal objective is the delay in bone-related symptoms in those
 patients with early zoledronate administration.
Inclusion Criteria:

 -  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
 (UNL)).

 -  Normal serum calcium levels.

 -  Performance status 0,1 (World Health Organization (WHO)).

 -  Negative pregnancy test before study recruitment.

 Exclusion Criteria:

 -  Previous treatment with bisphosphonates or raloxifene in the 30 days prior to
 randomization.

 -  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.

 -  Males.