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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)

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: 21 Nov 2025

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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

  • 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.
  • 24 Sep 2025 ENHERTU (5.4mg/kg) is approved in more than 40 countries 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) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.
  • 21 May 2025 According to an AstraZeneca media release, data from this trial will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting

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