Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions
Breast Cancer, Neoplasm Metastasis
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Non-symptomatic bone metastases.
Eligibility Criteria
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.
Sites / Locations
- Spanish Breast Cancer Research Group (GEICAM)
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Arm A: Zoledronic acid 4 mg
Arm B: Observation
Zoledronate 4 mg every 3 or 4 weeks. This arm will receive study treatment from the time of entry into the trial, until the appearance of the symptoms of bone metastases (or a maximum period of 12 months, whichever occurs first).
Patients will not receive any treatment with bisphosphonates until the time of onset of symptoms (or a maximum period of 12 months, whichever occurs sooner).