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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

StatusActive, Not Recruiting
PhasePhase 3
Started2022-08-04
View on ClinicalTrials.gov ↗

Amendment history

2025-08-18
Study Status, Arms and Interventions, Outcome Measures v3
Study arms2→4
InterventionsPyrotinib in combination with Capecitabine. (Drug), SHR-A1811 (Drug)→Pyrotinib in combination with Capecitabine. (Drug), SHR-A1811 (Drug), SHR-A1811 (Drug)
Secondary endpoints+792 characters
PFS（INV assessment）between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine ORR between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine； DoR between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine； OS between SHR-A1811 4.8mg/kg Q3W and [...]
Primary endpoints1 entry, revised
PFS（BIRC assessment）between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine.
2024-09-19
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-12-31→2026-12-31
Completion date2024-12-31→2027-12-31
Start date2022-07-29→2022-08-04
Enrollment targetestimated 269→confirmed 381
Study sitesdetails revised at 1 of 1 site
2022-08-08
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-07-15→confirmed 2022-07-29
Study sites0→1
2022-06-15
Original filing
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.
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