Some pivotal randomized clinical trials with breast cancer led by China
| Trials | Stage | Phenotypes | Experimental groups | Control groups | Primary endpoint | Result of primary endpoint |
|---|---|---|---|---|---|---|
| PEONY | Neoadjuvant | HER2-positive | TH+pertuzumab | TH | pCR | 39.3% vs. 21.8% |
| PHEDRA | Neoadjuvant | HER2-positive | TH+pyrotinib | TH | pCR | 41% vs. 22% |
| PHILA | First-line | HER2-positive | TH+pyrotinib | TH | PFS | 24.3 vs. 10.4 months |
| PHENIX | Second-line | HER2-positive | Pyrotinib+capecitabine | Capecitabine | PFS | 11.1 vs. 4.1 months |
| PHOEBE | Second-line | HER2-positive | Pyrotinib+capecitabine | Lapatinib+capecitabine | PFS | 12.5 vs. 6.8 months |
| cTRIO | Neoadjuvant | TNBC | TP+tislelizumab | – | pCR | 56.5% |
| NeoTennis | Neoadjuvant | TNBC | AC-T+toripalimab | – | pCR | 55.7% |
| SYSUCC-01 | Adjuvant | TNBC | Capecitabine | Placebo | 5y-DFS | 82.8% vs. 73.0% |
| TORCHLIGHT | First-line | TNBC | T+toripalimab | T | PFS | 8.4 vs. 5.6 months |
| Monarch plus | First-line | HR-positive | Cohort A: AI+abemaciclib Cohort B: F+abemaciclib | Cohort A: AI Cohort B: F | PFS | Cohort A: 14.7 vs. not reached Cohort B: 11.5 vs. 5.6 months |
| DAWNA-1 | Second-line | HR-positive | F+dalpiciclib | F | PFS | 15.7 vs. 7.2 months |
| DAWNA-2 | First-line | HR-positive | AI+dalpicclib | AI | PFS | 30.6 vs. 18.2 months |
| ACE | First-line | HR-positive | AI+chidamide | AI | PFS | 7.4 vs. 3.8 months |
T: taxane; H: trastuzumab; P: carboplatin; AC: by anthracycline with cyclophosphamide; AI: aromatase inhibitor; F: fulvestrant; pCR: pathologic complete remission; PFS: progression-free survival; DFS: disease-free survival; HER2: human epidermal growth factor receptor 2; TNBC: triple-negative breast cancer; HR: hormone receptor.