drugset / Trial / NCT05426486
A Study of ARX788 Combined With Pyrotinib Maleate Versus TCBHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, open label Phase II-III neoadjuvant study comparing the efficacy and safety of ARX788 combined with pyrotinib maleate versus TCBHP (trastuzumab plus pertuzumab with docetaxel and carboplatin) in patients with HER2-positive breast cancer.
Timeline
- Start
- 2022-05-23
- Primary completion
- 2025-12-30
- Completion
- 2028-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ANVATABART OPADOTIN | Other / unclassified | 1.5 mg/kg | Intravenous |
| Comparator | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Comparator | Docetaxel | Small molecule | 75 unknown | Intravenous |
| Comparator | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Subject | Pyrotinib | Small molecule | 320 mg | Oral |
| Comparator | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |