drugset / Trial / NCT04400695

A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2

NCT04400695 ↗

Phase 3 Recruiting 366 enrolled RemeGen Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will compare RC48-ADC to physician choice standard treatment. Participants must have HER2-low breast cancer ,previous use of anthracyclines, and have been treated with one or two systemic chemotherapy regimens following recurrence/metastasis.

Timeline

Start
2020-09-29
Primary completion
2027-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule — —
Subject Disitamab Vedotin Monoclonal antibody 2 mg/kg Intravenous
Comparator Docetaxel Small molecule — —
Comparator Paclitaxel Small molecule — —
Comparator Vinorelbine Small molecule — —

Indications