TABLE 3.
Update for Clinical trial data on HER2‐positive breast cancer brain metastases
| Clinical trial | Status | Treatment arms | Patients with BM | ORR (%) | mPFS (month) | mOS (month) |
|---|---|---|---|---|---|---|
| HER2CLIMB [213] | Has resultsF | All patients with BM | ||||
| Tucatinib/Trastuzumab/Cape | 198 | 47.3* | 9.9 | 21.6 | ||
| Trastuzumab/Cape | 93 | 20.0* | 4.2 | 12.5 | ||
| Has results | Active BM | |||||
| Tucatinib/Trastuzumab/Cape | 118 | NR | 9.6 | 21.4 | ||
| Trastuzumab/Cape | 56 | NR | 4.0 | 11.8 | ||
| Has results | Stable BM | |||||
| Tucatinib/Trastuzumab/Cape | 80 | NR | 13.9 | 21.6 | ||
| Trastuzumab/Cape | 37 | NR | 5.6 | 16.4 | ||
| NALA [212] | Has results | Neratinib/Cape | 51 | 28.6 | 5.6 | 13.9 |
| Lapatinib/Cape | 50 | 28.2 | 4.3 | 12.4 | ||
| TBCRC 022 [218] | Has results | Neratinib/Cape (lapatinib naive) | 37 | 49* | 5.5 | 13.3 |
| Neratinib/Cape (prior lapatinib) | 12 | 33* | 3.1 | 15.1 | ||
| PATRICIA [219] | Has results | Pertuzumab + High‐dose Trastuzumab | 39 | 11* | NR | NR |
| PERMEATE [214] | Has results | Pyrotinib/Cape (RT‐naïve) | 51 | 74.6 | 11.3 | NR |
| Pyrotinib/Cape (RT‐progressive) | 19 | 42.1 | 5.6 | NR | ||
| DESTINY Breast‐01 [209] | Has results | T‐DXd | 24 | 58.3 | 18.1 | NR |
| DESTINY Breast‐03 [210] | Has results | T‐DXd | 43 | 67.4 | 15.0 | NR |
| T‐DM1 | 39 | 20.5 | 3.0 | NR | ||
| KAMILLA [216] | Has results | T‐DM1 | 126 | 21.4 | 5.5 | 18.9 |
| NCT04334330 | Ongoing | Palbociclib + pyrotinib + trastuzumab + fulvestrant | N/A | N/A | N/A | N/A |
| NCT03765983 | Ongoing | GDC‐0084 (PI3K inhibitor) + trastuzumab | N/A | N/A | N/A | N/A |
| NCT03975647 | Ongoing |
Tucatinib + T‐DM1 Placebo + T‐DM1 |
N/A | N/A | N/A | N/A |
Abbreviations: BM, brain metastasis; NR, not reported; N/A, not applicable; ORR, overall response rate; mPFS, median progression free survival; mOS, median overall sruvival; RT,radiotherapy; T‐DXd, trastuzumab deruxtecan; T‐DM1, trastuzumab emtansine.
*
CNS ORR