Study identifier:D9670C00001
ClinicalTrials.gov identifier:NCT04494425
EudraCT identifier:2019-004493-26
CTIS identifier:N/A
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)
advanced or metastatic breast cancer
Phase 3
No
Trastuzumab deruxtecan, Capecitabine, Paclitaxel, Nab-Paclitaxel
All
866
Interventional
18 Years - 105 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jul 2024 by AstraZeneca
AstraZeneca
Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Trastuzumab deruxtecan Trastuzumab deruxtecan (T-DXd; DS-8201a) arm | Drug: Trastuzumab deruxtecan Trastuzumab deruxtecan by intravenous infusion Other Name: DS-8201a; T-DXd |
Active Comparator: Standard of Care Investigator’s choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm | Drug: Capecitabine Investigator’s choice standard of care single agent chemotherapy; capecitabine tablets will be given orally. Drug: Paclitaxel Investigator’s choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion. Drug: Nab-Paclitaxel Investigator’s choice standard of care single agent chemotherapy; nab-paclitaxel by intravenous infusion |