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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Detalhes bibliográficos
Autores: Cortés, A; López-Miranda, E; Fernández-Ortega, A; Carañana, V; Servitja, S; Urruticoechea, A; Lema-Roso, L; Márquez, A; Lazaris, A; Alcalá-López, D; Mina, L; Gener, P; Rodríguez-Morató, J; Antonarellij, G; Llombart-Cussac, A; Pérez-García, J; Cortés, J
Tipo de documento: Artigo
Estado:Published version
Data de publicação:2024
País:España
Recursos:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositório:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:dnet:r-fisabio___::88fefac86807016c894fde2a5c29c2c9
Acesso em linha:https://fisabio.portalinvestigacion.com/publicaciones/20687
Nível de acesso:Acesso aberto
Palavra-chave:Triple-negative breast cancer
PARP inhibitors
Olaparib
Germline BRCA1/2 mutations
Homologous recombination deficiency
Descrição
Resumo: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.