Table 1.
Summary of Current Clinical Trials Using Targeted Agents in Her2+ BCBM
| Author & Published Time | Study | Therapy | Phase | Intracranial ORR | mPFS (Months) | mOS (Months) |
|---|---|---|---|---|---|---|
| Guy Jerusalem et al 2022 Oct22 | DESTINY-Breast01 NCT03248492 | T-DXd | II | 58.3% | 18.1 | NA |
| José Manuel Pérez-García et al 2023. Jan8 | DEBBRAH NCT04420598 | T-DXd | II | 46.2% | NA | NA |
| Rupert Bartsch et al 2022. Sep23 | TUXEDO-1 NCT04752059 | T-DXd | II | 73.3% | 14 | NA |
| F Montemurro et al 2020 Oct5 | KAMILLA NCT01702571 | T-DM1 | IIIb | 21.4% | 5.5 | 18.9 |
| Nancy U Lin et al 2020 Aug14 | HER2CLIMB NCT02614794 | Tucatinib versus Placebo+Trastuzumab + Capecitabine | III | 47.3% versus 20.0% (P=0.03) | 9.9 versus 4.2 (P<0.0001) | 18.1 versus 12.0 (P=0.005) |
| Min Yan et al 2022 Mar16 | PERMEATE NCT03691051 | Pyrotinib + capecitabine | II | 74·6% in cohort A and 42·1% in cohort B | NA | NA |
| Sara A Hurvitz et al 2021 Aug20 | NALA NCT01808573 | Neratinib + capecitabine versus lapatinib + capecitabine | III | 26.3% versus 15.4% | 7.8 versus 5.5 (P=0.074) | 16.4 versus 15.4 (p=0.635) |
| Thomas Bachelot et al 2013 Jan12 | LANDSCAPE NCT00967031 | Lapatinib + capecitabine | II | 65·9% | 5·5 | 17·0 |
| Nancy U. Lin et al 2009 Feb11 | NCT00263588 | Lapatinib | II | 6% | 2.40 | 6.37 |
| Rachel A Freedman et al 2019 May19 | TBCRC 022 NCT01494662 | Neratinib and Capecitabine | II | 49% in cohort 3A and 33% in cohort 3B | 5.5 in cohort 3A and 3.1 in cohort 3B | 13.3 in cohort 3A and 15.1 in cohort 3B |
Notes: cohort A: radiotherapy-naive HER2-positive brain metastases; cohort B: progressive disease after radiotherapy; cohort 3A: Lapatinib-naïve, cohort 3B: lapatinib-treated.
Abbreviations: ORR, objective response rate; mPFS, median progression-free survival; mOS, median overall survival; NA, not available; T-DXd, trastuzumab deruxtecan; T-DM1, ado-trastuzumab emtansine.