Efficacy and safety of 12-weekly versus 4-weekly zoledronic acid for prolonged treatment of patients with bone metastases from breast cancer (ZOOM): a phase 3, open-label, randomised, non-inferiority trial.

Background: Zoledronic acid reduces skeletal-related events in patients with breast cancer, but concerns have been raised about prolonged monthly administration. We assessed the efficacy and safety of a reduced dosing frequency of zoledronic acid in women treated previously with monthly zoledronic acid.

Methods: We did this non-inferiority, phase 3 trial in 62 centres in Italy.

Efficacy and safety of zoledronic acid in patients with breast cancer metastatic to bone: a multicenter clinical trial.

Purpose: This study evaluated the efficacy and safety of zoledronic acid in breast cancer patients with newly diagnosed bone metastases.

Materials And Methods: Patients diagnosed with bone metastases < or = 6 weeks prior to first visit were enrolled. Zoledronic acid (4 mg) was administered via a 15-minute infusion every 3 or 4 weeks for 12 infusions.