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A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects With Advanced Breast Cancer

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A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects With Advanced Breast Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Feb 2024

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At a glance

  • Drugs Denosumab (Primary) ; Zoledronic acid
  • Indications Adenocarcinoma; Advanced breast cancer; Bone metastases; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Amgen

    • Most Recent Events

    • 19 Nov 2020 According to a BeiGene media release, the approval of XGEVA for the prevention of skeletal-related events (SREs) in patients with bone metastasis from solid tumors and MM was based on clinical results from four randomized international trials (NCT00321464, NCT00330759, NCT00321620, and NCT01345019).
    • 19 Nov 2020 According to a BeiGene media release, the China National Medical Products Administration (NMPA) has approved XGEVA (denosumab) for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors and in patients with multiple myeloma (MM).
    • 24 Jul 2020 Results (n=7379) of meta-analysis of four studies (NCT00321620, NCT00330759, NCT00321464 & NCT01345019) comparing the efficacy and tolerability of denosumab versus zoledronic acid (ZA) in the prevention of skeletal-related events (SREs) in patients with bone metastases secondary to solid tumors or bone lesions in multiple myeloma, published in the Clinical Therapeutics.

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