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: 13 Oct 2024
Price :
$35
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At a glance
- Drugs Trastuzumab-deruxtecan (Primary) ; Capecitabine; Paclitaxel
- Indications Advanced breast cancer; HER2 negative breast cancer
- Focus Registrational; Therapeutic Use
- Acronyms DB-06; DESTINY-Breast06
- Sponsors AstraZeneca; AstraZeneca AB
- 04 Oct 2024 According to Daiichi Sankyo media release, based on results form this trial the company has submitted a supplemental New Drug Application (sNDA) to Japan's Ministry of Health, Labour and Welfare for ENHERTU for the treatment of adult patients with HER2 low or ultralow unresectable or recurrent breast cancer. Additional regulatory submissions for ENHERTU based on data from DESTINY-Breast06 are under review in the EU and U.S.
- 01 Oct 2024 According to Daiichi Sankyo media release, data from this trial was published in The New England Journal of Medicine.
- 01 Oct 2024 According to Daiichi Sankyo media release, based on results form this trial the sBLA for ENHERTU (famtrastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting. The PDUFA date form this application is February 1, 2025.