Table 1 Clinical studies on neoadjuvant therapy using pyrotinib
From: Pyrotinib-based therapeutic approaches for HER2-positive breast cancer: the time is now
No. | Registration ID | Title | Target sample size | Outcomes |
|---|---|---|---|---|
1 | ChiCTR2100052892 | Pyrotinib as neoadjuvant treatment for HER2-positive breast cancer: a single-arm, multicenter, prospective observational trial | 100 | pCR, EFS, DFS, DMFS, ORR |
2 | ChiCTR2100048136 | Trastuzumab combined with pertuzumab and sequential use of pyrotinib vs trastuzumab combined with pertuzumab for adjuvant treatment of non-pCR HER2-positive breast cancer after neoadjuvant therapy: a prospective, randomized control, stage iii clinical trial | 450 | iDFS, DFS, OS, DDFS |
3 | ChiCTR2100047086 | Single-Arm, Multicenter Clinical Study of Pyrotinib Maleate Tablets Combined with Albumin-Bound Paclitaxel and Trastuzumab in Neoadjuvant Treatment of Her2-positive Early or Locally Advanced Breast Cancer | 199 | pCR, ORR, DCR, bpCR, safety |
4 | ChiCTR2000034827 | Pyrotinib maleate, CDK4/6 inhibitor and letrozole in combination for treatment of stage II–III triple-positive breast cancer: a phase II clinical trial | 89 | tpCR, BORR, RCB, OS, DFS |
5 | ChiCTR1900028212 | A multicenter, prospective, single-arm, exploratory clinical study of neoadjuvant therapy of her2-positive breast cancer with pyrotinib maleate tablets combined with paclitaxel for injection (albumin-bound) | 90 | pCR, EFS, DFS, DDFS, ORR safety |
6 | ChiCTR1900026200 | Neoadjuvant chemotherapy with pyrotinib, trastuzumab, docetaxel, and carboplatin in combination for locally advanced epidermal growth factor receptor 2-positve breast cancer: a multicenter, randomized, open-label, parallel-group controlled phase III trial | 532 | tpCR, ORR, ECOG PS, safety |
7 | ChiCTR1800020226 | Prospective, open-label, multicenter trial for pyrotinib plus trastuzumab, carboplatin, and docetaxel in the treatment of HER2-positive breast cancer | 236 | tpCR, EFS, DFS, ORR, DDFS |
8 | ChiCTR2200062936 | Pyrotinib as neoadjuvant treatment for HER2-positive breast cancer | 300 | pCR, DMFS, ORR, OS, safety |
9 | NCT04917900 | Single-arm, Multicenter Clinical Study of Pyrotinib Maleate Tablets Combined with Albumin-bound Paclitaxel and Trastuzumab in Neoadjuvant Treatment of HER2-positive Early or Locally Advanced Breast Cancer | 199 | pCR, ORR, DCR, bpCR, AEs |
10 | NCT04900311 | Pyrotinib Versus Pertuzumab in Combination with Neoadjuvant Trastuzumab and Nab-Paclitaxel in HER2+ Early or Locally Advanced Breast Cancer | 490 | tpCR, iDFS, EFS, ORR, BCS rate |
11 | NCT03847818 | Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Chemotherapy in Patients with HER2 Positive Breast Cancer | 268 | pCR, EFS, DFS, DDFS, ORR |
12 | NCT04872985 | Pyrotinib in Combination with Neoadjuvant Chemotherapy in HR+ /HER2−, HER4 High Expression Breast Cancer Patients: A Phase II Trial | 140 | tpCR, pCR, ORR, EFS, OS |
13 | NCT04398914 | Pyrotinib, Trastuzumab, Pertuzumab and Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer | 216 | tpCR, bpCR, EFS, DFS, OS |
14 | NCT03588091 | Neoadjuvant Study of Pyrotinib in Combination with Trastuzumab in Patients with HER2 Positive Breast Cancer | 355 | pCR evaluated by IRC, pCR evaluated by sites, EFS, DFS, DDFS, ORR |
15 | NCT03756064 | Neoadjuvant Study of Pyrotinib in Patients with HER2 Positive Breast Cancer | 100 | pCR, EFS, DFS, DDFS, ORR |
16 | NCT04290793 | Neoadjuvant Chemotherapy with Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER2+ Breast Cancer | 280 | pCR, ORR, EFS, DFS, OS |
17 | NCT05561686 | Real-world Study of Pyrotinib in Neoadjuvant Therapy for HER2-positive Breast Cancer | 100 | tpCR, bpCR, ORR, AEs |
18 | NCT05426486 | A Randomized, Open-Label, Multicenter Phase II–III Neoadjuvant Study Comparing the Efficacy and Safety of ARX788 Combined with Pyrotinib Maleate Versus TCBHP (Trastuzumab Plus Pertuzumab with Docetaxel and Carboplatin) in Patients with HER2-positive Breast Cancer | 150 | tpCR, bpCR, RCB, BORR, OS, DFS, AEs |