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

A Phase III, Multicenter, Randomized, Open-Label, Parallel Controlled Study of SHR-A1811 Versus Pyrotinib in Combination With Capecitabine for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

Interventions

Type	Name	Description
DRUG	SHR-A1811	SHR-A1811 4.8mg/kg
DRUG	Pyrotinib in combination with Capecitabine.	Pyrotinib in combination with Capecitabine.
DRUG	SHR-A1811	SHR-A1811 6.4mg/kg

Timeline

• Start date: 2022-08-04
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2022-06-21
• Last updated: 2025-08-22

Locations

1 site across 1 country: China