RT Journal Article
T1 Trastuzumab deruxtecan in patients with central nervous system involvement from HER2-positive breast cancer: The DEBBRAH trial.
A1 Perez-Garcia, Jose Manuel
A1 Vaz Batista, Marta
A1 Cortez, Patricia
A1 Ruiz-Borrego, Manuel
A1 Cejalvo, Juan Miguel
A1 de la Haba-Rodriguez, Juan
A1 Garrigos, Laia
A1 Racca, Fabricio
A1 Servitja, Sonia
A1 Blanch, Salvador
A1 Gion, Maria
A1 Nave, Monica
A1 Fernandez-Abad, Maria
A1 Martinez-Bueno, Alejandro
A1 Llombart-Cussac, Antonio
A1 Sampayo-Cordero, Miguel
A1 Malfettone, Andrea
A1 Cortes, Javier
A1 Braga, Sofia
K1 HER2-positive
K1 T-DXd
K1 Advanced breast cancer
K1 Brain metastases
K1 Trastuzumab deruxtecan
AB Trastuzumab deruxtecan (T-DXd) has shown durable antitumor activity in pretreated patients with HER2-positive advanced breast cancer (ABC), but its efficacy has not yet been evaluated in patients with active brain metastases (BMs). DEBBRAH aims to assess T-DXd in patients with HER2-positive or HER2-low ABC and central nervous system involvement. This ongoing, five-cohort, phase II study (NCT04420598) enrolled patients with pretreated HER2-positive or HER2-low ABC with stable, untreated, or progressing BMs, and/or leptomeningeal carcinomatosis. Here, we report findings from HER2-positive ABC patients with non-progressing BMs after local therapy (n = 8; cohort 1), asymptomatic untreated BMs (n = 4; cohort 2), or progressing BMs after local therapy (n = 9; cohort 3). Patients received 5.4 mg/kg T-DXd intravenously once every 21 days. The primary endpoint was 16-week progression-free survival (PFS) for cohort 1 and intracranial objective response rate (ORR-IC) for cohorts 2 and 3. As of October 20, 2021, 21 patients received T-DXd. In cohort 1, 16-week PFS rate was 87.5% (95%CI, 47.3-99.7; P  T-DXd showed intracranial activity with manageable toxicity and maintained the quality of life in pretreated HER2-positive ABC patients with stable, untreated, or progressing BMs. Further studies are needed to validate these results in larger cohorts.
PB Oxford University Press
YR 2023
FD 2023
LK http://hdl.handle.net/10668/19821
UL http://hdl.handle.net/10668/19821
LA en
NO Pérez-García JM, Vaz Batista M, Cortez P, Ruiz-Borrego M, Cejalvo JM, de la Haba-Rodriguez J, et al. Trastuzumab deruxtecan in patients with central nervous system involvement from HER2-positive breast cancer: The DEBBRAH trial. Neuro Oncol. 2023 Jan 5;25(1):157-166
DS RISalud
RD Apr 7, 2025