drugset / Trial / NCT03500380

A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases

NCT03500380

Phase 2/3 Unknown 301 enrolled RemeGen Co., Ltd.
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

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule 2000 mg/m2 Oral
Subject Disitamab Vedotin Monoclonal antibody 2 mg/kg Intravenous
Comparator Lapatinib Small molecule 1250 mg Oral