%0 Journal Article
%A Perez-Garcia, Jose Manuel
%A Vaz Batista, Marta
%A Cortez, Patricia
%A Ruiz-Borrego, Manuel
%A Cejalvo, Juan Miguel
%A de la Haba-Rodriguez, Juan
%A Garrigos, Laia
%A Racca, Fabricio
%A Servitja, Sonia
%A Blanch, Salvador
%A Gion, Maria
%A Nave, Monica
%A Fernandez-Abad, Maria
%A Martinez-Bueno, Alejandro
%A Llombart-Cussac, Antonio
%A Sampayo-Cordero, Miguel
%A Malfettone, Andrea
%A Cortes, Javier
%A Braga, Sofia
%T Trastuzumab deruxtecan in patients with central nervous system involvement from HER2-positive breast cancer: The DEBBRAH trial.
%D 2023
%U http://hdl.handle.net/10668/19821
%X 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.
%K HER2-positive
%K T-DXd
%K Advanced breast cancer
%K Brain metastases
%K Trastuzumab deruxtecan
%~