Clinical Trial

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

Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-06-15; most recent amendment 2025-08-18.
Status change: Recruiting → Active, Not Recruiting 2024-09-19
Status change: Not Yet Recruiting → Recruiting 2022-08-08
Trial Details
NCT Number NCT05424835
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
Enrollment 381 participants
Start Date 2022-08-04
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-22