drugset / Trial / NCT06018337
A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+, HER2-low (immunohistochemistry \[IHC\]2+/in situ hybridization \[ISH\]- and IHC 1+) population.
Timeline
- Start
- 2024-01-18
- Primary completion
- 2026-06
- Completion
- 2028-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Comparator | Paclitaxel | Small molecule | 100 mg/m2 | — |
| Subject | TRASTUZUMAB PAMIRTECAN | Unknown | 8 mg/kg | Intravenous |