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A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)

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Trial Profile

A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)

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

Latest Information Update: 18 Mar 2026

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At a glance

  • Drugs Trastuzumab-deruxtecan (Primary) ; Capecitabine; Paclitaxel
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms DB-06; DESTINY-Breast06
  • Sponsors AstraZeneca; AstraZeneca AB

Most Recent Events

  • 27 Feb 2026 According to Daiichi Sankyo media release, based on the results of DESTINY-Breast04 trial, ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining).
  • 07 Jan 2026 According to Daiichi Sankyo media release, ENHERTU Approved in China as First HER2 Directed Medicine for Patients with HER2 Low or HER2 Ultralow Metastatic Breast Cancer Following Disease Progression After One or More Endocrine Therapies. based on results from the DESTINY-Breast06 phase 3 trial presented at the 2024 American Society of Clinical Oncology (#ASCO24) Annual Meeting and published in The New England Journal of Medicine.
  • 29 Oct 2025 According to Daiichi Sankyo media release, Health Canada has granted a Notice of Compliance (NOC) for Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer.

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