drugset / Trial / NCT05424835

A Trial of SHR-A1811versus Pyrotinib in Combination With Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

NCT05424835

Phase 3 Active not recruiting 381 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

The study is being conducted to evaluate whether the efficacy of SHR-A1811 is better than Pyrotinib in combination with Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane.

Timeline

Start
2022-08-04
Primary completion
2026-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule 1000 mg/m2 Oral
Comparator Pyrotinib Small molecule 400 mg Oral
Subject Trastuzumab Rezetecan Monoclonal antibody 4.8 mg/kg Intravenous
Subject Trastuzumab Rezetecan Monoclonal antibody 6.4 mg/kg Intravenous