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. 2023 Oct 3;25:113. doi: 10.1186/s13058-023-01694-5

Table 2.

Clinical studies on adjuvant therapy using pyrotinib

No. Registration ID Title Target sample size Outcomes
1 ChiCTR2200058746 Multicenter cohort study on efficacy and safety of HER2-positive, node-positive breast cancer following intensive adjuvant or neoadjuvant anti-HER2 therapy with pyrotinib 200 iDFS, DDFS, OS
2 ChiCTR2100049018 A randomized, open-label, multicenter study to evaluate the efficacy and safety of continuation of original targeted therapy versus Trastuzumab combined with Pyrotinib and capecitabine as postoperative adjuvant therapy in patients with HER2-positive early breast cancer who have residual tumor present pathologically following 206 3-year iDFS rate
3 ChiCTR2000040866 Comparison of Pyrotinib or Pertuzumab Combined with Trastuzumab for non-pCR HER2 Positive Breast Cancer after Neoadjuvant Therapy: A Randomized, Open, Prospective Clinical Study 546 iDFS, DFS, OS, BCSS, safty
4 ChiCTR2000038503 Pyrotinib and Trastuzumab for Early or Local Advanced HER2-Positive Breast Cancer 97 iDFS, OS, DFS, DDFS, safty
5 NCT04254263 Adjuvant Study of Pyrotinib in HER2 Positive Breast Cancer (ATP) 316 iDFS, DFS, OS
6 NCT04659499 Nab-paclitaxel in Combination with Pyrotinib in Postoperative Adjuvant Therapy for HER2-positive Breast Cancer 261 3-year DFS, AEs + SAEs
7 NCT03980054 A Study of Evaluating the Effects of Pyrotinib After Adjuvant Trastuzumab in Women with Early stage Breast Cancer 1192 iDFS, DFS, OS, DDFS
8 NCT05292742 Compare Continuation of Original Targeted Therapy with Trastuzumab Combined with Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in Non-pCR Patients with HER2 Positive Early Breast Cancer 206 iDFS

iDFS invasive disease-free survival; DDFS distant disease-free survival; OS overall survival; DFS disease-free survival; BCSS breast cancer-specific survival; AEs adverse events; SAEs severe adverse events