Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
Summary
This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.
Timeline
- Start
- 2021-10-25
- Primary completion
- 2025-03-12
- Completion
- 2027-04-30
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry analysis (superiority test); Arm A vs Arm C; p = 0.001; M&N estimate of difference in rates -13.18 (95% CI -20.84 to -5.41) reads as mixed primary results NCT05113251 ↗
registry analysis (superiority test); Arm B vs Arm C; p = 0.003; M&N estimate of difference in rates 11.17 (95% CI 3.95 to 18.28) reads as mixed primary results NCT05113251 ↗
release “In DESTINY-Breast11, Enhertu followed by THP resulted in a pCR rate of 67.3% compared with 56.3% for ddAC-THP” reads as met primary endpoint astrazeneca.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | — | Intravenous |
| Subject | Paclitaxel | Small molecule | — | Intravenous |
| Subject | Pertuzumab | Monoclonal antibody | — | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | — | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | — | Intravenous |