Olaparib monotherapy in advanced triple-negative breast cancer patients with homologous recombination deficiency and without germline mutations in BRCA1/2: The NOBROLA phase 2 study

Purpose: To evaluate olaparib in advanced triple negative breast cancer (TNBC) patients with homologous recombination deficiency (HRD) and no germline BRCA1/2 mutations (gBRCA1/2mut). Methods: NOBROLA (NCT03367689) is a single-arm, open-label, multicenter, phase IIa trial, enrolling adult patients w...

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Detalles Bibliográficos
Autores: Cortés, Alfonso, López-Miranda, Elena, Fernández-Ortega, Adela, Carañana, Vicente, Servitja Tormo, Sonia, Urruticoechea, Ander, Lema-Roso, Laura, Márquez, Antonia, Lazaris, Alexandros, Alcalá-López, Daniel, Mina, Leonardo, Gener, Petra, Rodríguez-Morató, Jose, 1987-, Antonarelli, Gabriele, Llombart-Cussac, Antonio, Pérez-García, José, Cortés, Javier
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:10230/71633
Acceso en línea:http://hdl.handle.net/10230/71633
http://dx.doi.org/10.1016/j.breast.2024.103834
Access Level:acceso abierto
Palabra clave:Germline BRCA1/2 mutations
Homologous recombination deficiency
Olaparib
PARP inhibitors
Triple-negative breast cancer
Descripción
Sumario:Purpose: To evaluate olaparib in advanced triple negative breast cancer (TNBC) patients with homologous recombination deficiency (HRD) and no germline BRCA1/2 mutations (gBRCA1/2mut). Methods: NOBROLA (NCT03367689) is a single-arm, open-label, multicenter, phase IIa trial, enrolling adult patients with advanced TNBC without gBRCA1/2mut and with HRD, who were treated with olaparib. The primary endpoint was clinical benefit rate (CBR) per RECIST v.1.1. Results: Six of 114 patients were eligible and received olaparib. Median follow up was 8.5 months. CBR and overall response rate (ORR) were 50 % (95 % CI, 11.8-88.2). Conclusions: The observed results could prompt further investigation. Trial: ClinicalTrials.gov identifier NCT03367689.