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A Phase 3, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy and Safety of Zanidatamab in Combination With Physician's Choice Chemotherapy Compared to Trastuzumab in Combination With Physician's Choice Chemotherapy for the Treatment of Participants With Metastatic HER2-positive Breast Cancer Who Have Progressed on, or Are Intolerant to, Previous Trastuzumab Deruxtecan Treatment

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Trial Profile

A Phase 3, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy and Safety of Zanidatamab in Combination With Physician's Choice Chemotherapy Compared to Trastuzumab in Combination With Physician's Choice Chemotherapy for the Treatment of Participants With Metastatic HER2-positive Breast Cancer Who Have Progressed on, or Are Intolerant to, Previous Trastuzumab Deruxtecan Treatment

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Mar 2025

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At a glance

  • Drugs Zanidatamab (Primary) ; Antineoplastics; Capecitabine; Eribulin; Gemcitabine; Trastuzumab; Vinorelbine
  • Indications Advanced breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms EMPOWHER; EmpowHER-303
  • Sponsors Jazz Pharmaceuticals Inc

    • Most Recent Events

    • 13 Dec 2024 Trial design presented at the 47th Annual San Antonio Breast Cancer Symposium
    • 03 Dec 2024 According to Jazz Pharmaceuticals media release, data from the study will be presented at the 66th Annual American Society of Hematology (ASH) Annual Meeting from December 7-10.
    • 01 Aug 2024 Planned End Date changed from 25 Apr 2031 to 26 Nov 2031.

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