At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Pathologically documented advanced or metastatic breast cancer
- ✓HER2-low or negative expression by local test (IHC 2+/ISH-, IHC 1+, or IHC 0)
- ✓HER2-low or HER2 IHC >0 <1+ expression confirmed by central laboratory on tissue from metastatic setting
- ✕Ineligible for all options in the investigator's choice chemotherapy arm
- ✕Lung-specific intercurrent clinically significant illnesses
- ✕Uncontrolled or significant cardiovascular disease or infection
- ✕Prior interstitial lung disease (ILD) or pneumonitis requiring steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis not ruled out by imaging at screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Trastuzumab deruxtecan, Capecitabine, and 2 other interventions for Advanced or Metastatic Breast Cancer. Active but no longer recruiting, targeting 866 participants across 293 sites in 28 countries.
Detailed 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.
Study Details
Timeline
Interventions
Trastuzumab deruxtecan by intravenous infusion
Investigator's choice standard of care single agent chemotherapy; capecitabine tablets will be given orally.
Investigator's choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion.
Investigator's choice standard of care single agent chemotherapy; nab-paclitaxel by intravenous infusion