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A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

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Trial Profile

A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

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

Latest Information Update: 16 May 2024

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At a glance

  • Drugs Datopotamab deruxtecan (Primary) ; Capecitabine; Eribulin; Gemcitabine; Gemcitabine; Vinorelbine
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms TB-01; TROPION-Breast01
  • Sponsors AstraZeneca; AstraZeneca AB
  • Most Recent Events

    • 16 May 2024 This study has been Completed in Netherlands, According to European Clinical Trials Database record.
    • 02 Apr 2024 According to an AstraZeneca media release, A BLA for datopotamab deruxtecan based on results from this trial has been accepted in the US for the treatment of adult patients with unresectable or mHR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior systemic therapy for unresectable or metastatic disease. And, The Prescription Drug User Fee Act date, the US FDA action date for its regulatory decision, is during the first quarter of 2025.
    • 04 Mar 2024 According to a Daiichi Sankyo Media Release, the European Medicines Agency (EMA) has validated MAA for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy and received at least one additional systemic therapy, based on results from this trial.
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