Clinical Trial: NCT04494425
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-03-04 |
Study Overview
Brief Summary
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
Official Title
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)
Conditions
Advanced or Metastatic Breast Cancer
Intervention / Treatment
- Drug: Trastuzumab deruxtecan
- Drug: Capecitabine
- Drug: Paclitaxel
- Drug: Nab-Paclitaxel
Other Study ID Numbers
- D9670C00001
- 2023-505554-18-00
- 2019-004493-26
- 2019
- 2023
Start Date (Actual)
2020-07-24
Primary Completion Date (Actual)
2024-03-18
Study Completion Date (Estimated)
2026-06-19
Enrollment (Actual)
866
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-03-04 |
Study Overview
Brief Summary
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
Official Title
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)
Conditions
Advanced or Metastatic Breast Cancer
Intervention / Treatment
- Drug: Trastuzumab deruxtecan
- Drug: Capecitabine
- Drug: Paclitaxel
- Drug: Nab-Paclitaxel
Other Study ID Numbers
- D9670C00001
- 2023-505554-18-00
- 2019-004493-26
- 2019
- 2023
Start Date (Actual)
2020-07-24
Primary Completion Date (Actual)
2024-03-18
Study Completion Date (Estimated)
2026-06-19
Enrollment (Actual)
866
Study Type
Interventional
Phase
Phase 3