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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: 31 Jul 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

  • 24 Jul 2026 According to Daiichi Sankyo media release, Enhertu (5.4 mg/kg) is approved in more than 75 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic 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.
  • 26 May 2026 According to Clinical Trials Information System, this trial has been completed in Portugal and Netherlands.
  • 26 May 2026 According to Clinical Trials Information System, this trial has been completed in Portugal and Netherlands.

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