Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)
Summary
The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with Human epidermal growth factor receptor 2 (HER2)-positive breast cancer as a first line of treatment in the metastatic setting.
Timeline
- Start
- 2021-04-26
- Primary completion
- 2026-07-06
- Completion
- 2029-12-30
Outcome
Met primary endpoint
paper Trastuzumab deruxtecan plus pertuzumab led to a significantly lower risk of progression or death than THP PMID 41160818 ↗
release “DESTINY-Breast09 Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu is the first trial in more than a decade to demonstrate superior efficacy” astrazeneca.com ↗
release “DESTINY-Breast09 Phase III trial showed Enhertu (trastuzumab deruxtecan) plus pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival” astrazeneca.com ↗
release “Based on DESTINY-Breast09 Phase III trial results which showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% vs. THP” astrazeneca.com ↗
release “Enhertu plus pertuzumab in DESTINY-Breast09 sets a new benchmark of more than three years without disease progression or death” astrazeneca.com ↗
release “In the trial, Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% versus a taxane, trastuzumab and pertuzumab (THP)” astrazeneca.com ↗
release “DESTINY-Breast09 Phase III trial showed Enhertu (trastuzumab deruxtecan) plus pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS)” astrazeneca.com ↗
release “DESTINY-Breast09 Phase III trial results that showed AstraZeneca and Daiichi Sankyo’s Enhertu in combination with pertuzumab reduced the risk of disease progression or death” astrazeneca.com ↗
release “In DESTINY-Breast09, Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% versus a taxane, trastuzumab and pertuzumab (THP)” astrazeneca.com ↗
release “Median progression-free survival (PFS) was 40.7 months with Enhertu in combination with pertuzumab compared to 26.9 months with THP.” astrazeneca.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Docetaxel | Small molecule | — | Intravenous |
| Comparator | Paclitaxel | Small molecule | — | Intravenous |
| Subject | Pertuzumab | Monoclonal antibody | — | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | — | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | — | Intravenous |