drugset / Trial / NCT03500380
A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases
RandomizedCrossoverOpen-labelTreatment
Summary
This is a randomized, open, parallel-controlled, multicenter, phase II/III, seamless design clinical trial to compare the efficacy and safety of RC48-ADC with capecitabine + lapatinib in locally advanced or metastatic human epidermal growth factor receptor 2 (HER2) positive breast cancer and HER2-positive advanced breast cancer with liver metastasis.
Timeline
- Start
- 2018-04-24
- Primary completion
- 2024-07-31
- Completion
- 2024-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 2000 mg/m2 | Oral |
| Subject | Disitamab Vedotin | Monoclonal antibody | 2 mg/kg | Intravenous |
| Comparator | Lapatinib | Small molecule | 1250 mg | Oral |