OCTS-03 A MULTICENTER, OPEN-LABEL, SINGLE-ARM, MULTICOHORT PHASE II CLINICAL TRIAL OF TRASTUZUMAB DERUXTECAN IN HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-POSITIVE AND HER2-LOW ADVANCED BREAST CANCER (ABC) WITH BRAIN METASTASES AND/OR LEPTOMENINGEAL CARCINOMATOSIS (LMC) – THE DEBBRAH STUDY

• Published in: Neuro-oncology advances 2024-08, Vol.6 (Supplement_1), p.i26-i27
• Main Authors: Vaz-Batista, Marta, Pérez-García, José Manuel, Cortez, Patricia, Garrigós, Laia, Ruiz-Borrego, Manuel, de la Haba-Rodríguez, Juan, de las Heras, Begoña Bermejo, Servitja, Sonia, Racca, Fabricio, Fernández-Abad, María, Blanch, Salvador, Teurel, Iris, Sáenz1, Jose Ángel Garcia, Ortega, Adela Fernandez, Martrat, Griselda, Shimizu, Eileen, Alcalá-López, Daniel, Pérez-Escuredo, Jhudit, Braga, Sofia, Llombart-Cussac, Antonio, Cortes, Javier
• Format: Article
• Language: English
• Subjects: Final Category: Ongoing Clinical Trials
• ISSN: 2632-2498; 2632-2498
• DOI: 10.1093/noajnl/vdae090.088

Abstract The DEBBRAH study (NCT04420598) evaluated the efficacy and safety of trastuzumab deruxtecan (T-DXd), an antibody-drug conjugate, in patients with HER2-positive and HER2-low ABC with brain metastases (BM) and/or LMC. Forty-one patients aged ≥18 years were enrolled in 5 cohorts: (1) HER2-positive ABC with non-progressing BM after radiotherapy and/or surgery (n=8); (2) HER2-positive or HER2-low ABC with asymptomatic untreated BM (n=10); (3) HER2-positive ABC with progressing BM after local treatment (n=9); (4) HER2-low ABC with progressing BM after local treatment (n=7); (5) HER2-positive or HER2-low ABC and pathologically confirmed LMC (n=7). Patients received 5.4 mg/kg T-DXd intravenously once every 21 days until disease progression, unacceptable toxicity, or consent withdrawal. At the final analysis cut-off (4th April 2023), with a median follow-up of 15.2 months (range 2.1-30.1), three (7.3%) patients were still receiving T-DXd. In cohort 1, the 16-week progression-free survival rate was 87.5% (p