drugset / Trial / NCT07203729
The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic Breast Cancer Patients With Visceral Crisis
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to learn if Trastuzumab Rezetecan (SHR-A1811) is safe and tolerable for patients with HER2-Low unresectable/metastatic breast cancer complicated with visceral crisis. Participants will take Trastuzumab Rezetecan every three weeks, until disease progression or intolerable toxicity.
Timeline
- Start
- 2026-03-01
- Primary completion
- 2030-06-15
- Completion
- 2030-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | — | — |
| Comparator | Eribulin | Small molecule | — | — |
| Comparator | Gemcitabine | Small molecule | — | — |
| Comparator | Nab-paclitaxel | Small molecule | — | — |
| Subject | Trastuzumab Rezetecan | Monoclonal antibody | 4.8 mg/kg | Intravenous |
| Comparator | Vinorelbine | Small molecule | — | — |