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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: 27 May 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

  • 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
  • 04 Apr 2025 According to Daiichi Sankyo media release, ENHERTU has been approved in the European Union as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low or HER2 ultralow breast cancer. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results from the DESTINYBreast06.
  • 28 Feb 2025 According to Daiichi Sankyo media release, based on results form this trial the Committee for Medicinal Products for Human Use of the European Medicines Agency has given positive opinion for approval of ENHERTU for approval in the European Union (EU) as a monotherapy 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.

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