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A phase 3, multicenter, randomized, open-label, active-controlled trial of trastuzumab deruxtecan (T-DXd), an anti-HER2-antibody drug conjugate (ADC), versus treatment of physician's choice for HER2-Low, unresectable and/or metastatic breast cancer subjects (DESTINY-Breast04)

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Trial Profile

A phase 3, multicenter, randomized, open-label, active-controlled trial of trastuzumab deruxtecan (T-DXd), an anti-HER2-antibody drug conjugate (ADC), versus treatment of physician's choice for HER2-Low, unresectable and/or metastatic breast cancer subjects (DESTINY-Breast04)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Apr 2024

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At a glance

  • Drugs Trastuzumab-deruxtecan (Primary) ; Capecitabine; Eribulin; Gemcitabine; Paclitaxel
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms DESTINY-B04; DESTINY-Breast04
  • Sponsors Daiichi Sankyo Inc

    • Most Recent Events

    • 10 Apr 2024 According to an AstraZeneca media release, pre-diluted VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx was used as part of the DESTINY-Breast04 trial to identify patients whose tumours expressed low levels of HER2 protein (IHC 1+ or IHC 2+/ISH-).
    • 09 Apr 2024 Planned End Date changed from 1 Mar 2024 to 1 Oct 2025.
    • 24 Oct 2023 Results (n=35) of exploratory analysis assessing additional intracranial efficacy data in patients with brain metastases at baseline, presented at the 48th European Society for Medical Oncology Congress.
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