Table 1. Summary of clinical trials related to HER2DX.
| Trial | Clinical trials number | Intervention | Phase | Patient population | Rate of pCR | Molecular typing | Ref. |
|---|---|---|---|---|---|---|---|
| CALGB-40601 | NCT00770809 | Paclitaxel + trastuzumab + lapatinib or paclitaxel + trastuzumab or paclitaxel + lapatinib | III | 305 | THP: 56%, 95% CI: 47–65%; TH: 46%, 95% CI: 37–55%; TL: 32%, 95% CI: 22–45% | HER2+ | (11) |
| ISPY-2 | NCT01042379 | T-DM1 + pertuzumab or paclitaxel + trastuzumab + pertuzumab, or a control arm of paclitaxel + trastuzumab. Doxorubicin + cyclophosphamide before surgery | II | 128 | T-DM1/P: 55%, 95% PI: 41–69%; THP: 56%, 95% PI: 42–70%; TH: 25%, 95% PI: 11–38% | HER2+ | (11,12) |
| PAMELA | NCT01973660 | Trastuzumab + lapatinib ± letrozole or tamoxifen | II | 151 | 41%, 95% CI: 31–51% | HER2+ | (13) |
| PerELISA | NCT02411344 | – | – | – | – | HER2+ | (14) |
| DAPHNe | NCT03716180 | Paclitaxel + trastuzumab + pertuzumab before surgery | II | 98 | 56.7% | HER2+ | (15) |
| BiOnHER | NCT05912062 | Trastuzumab + pertuzumab without chemotherapy followed by + trastuzumab + pertuzumab | II | 49 | 45.6% | HER2+ | (11) |
| NEOHER | – | Docetaxel + pertuzumab + trastuzumab ± carboplatin | – | 44 | THP: 66.7%; THCP: 78.6% | HER2+ | (16) |
| GOM | – | Docetaxel + carboplatin + trastuzumab ± pertuzumab | – | 155 | TCH: 57%, 95% CI: 49–65%; TCHP: 61%, 95% CI: 50–71% | HER2 | (11,12) |
| PHERGain | NCT03161353 | Trastuzumab + pertuzumab+ endocrine therapy docetaxel + pertuzumab + trastuzumab + carboplatin | II | 356 | TCHP: 56.4%; HP: 33.8% | HER2+ | (17) |
CI, confidence interval; HER2+, human epidermal growth factor receptor 2-positive; P, pertuzumab; pCR, pathological complete response; PI, probability interval; ref., reference; TCH, docetaxel, carboplatin, and trastuzumab; TCHP, docetaxel, carboplatin, trastuzumab, and pertuzumab; TH, docetaxel-trastuzumab; THP, docetaxel, trastuzumab, and pertuzumab; TL, docetaxel-lobaplatin; T-DM1, trastuzumab emtansine.