Clinical 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
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Jiangsu HengRui Medicine Co., Ltd. |
| Information Provided By: | Jiangsu HengRui Medicine Co., Ltd. |
| Last Update Posted: | 2025-08-22 |
Study Overview
Brief 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.
Official Title
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
Conditions
HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
Intervention / Treatment
- Drug: SHR-A1811
- Drug: Pyrotinib in combination with Capecitabine.
- Drug: SHR-A1811
Other Study ID Numbers
- SHR-A1811-III-301
Start Date (Actual)
2022-08-04
Primary Completion Date (Estimated)
2026-12-31
Study Completion Date (Estimated)
2027-12-31
Enrollment (Actual)
381
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Jiangsu HengRui Medicine Co., Ltd. |
| Information Provided By: | Jiangsu HengRui Medicine Co., Ltd. |
| Last Update Posted: | 2025-08-22 |
Study Overview
Brief 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.
Official Title
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
Conditions
HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
Intervention / Treatment
- Drug: SHR-A1811
- Drug: Pyrotinib in combination with Capecitabine.
- Drug: SHR-A1811
Other Study ID Numbers
- SHR-A1811-III-301
Start Date (Actual)
2022-08-04
Primary Completion Date (Estimated)
2026-12-31
Study Completion Date (Estimated)
2027-12-31
Enrollment (Actual)
381
Study Type
Interventional
Phase
Phase 3