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
Alfonso Cortés,
Elena López-Miranda,
Adela Fernández-Ortega,
Vicente Carañana,
Sonia Servitja,
Ander Urruticoechea,
Laura Lema-Roso,
Antonia Márquez,
Alexandros Lazaris,
Daniel Alcalá-López,
Leonardo Mina,
Petra Gener,
Jose Rodríguez-Morató,
Gabriele Antonarelli,
Antonio Llombart-Cussac,
José Pérez-García,
Javier Cortés
Affiliations
Alfonso Cortés
Hospital Universitario Ramón y Cajal, Madrid, Spain
Elena López-Miranda
Hospital Universitario Ramón y Cajal, Madrid, Spain; Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey, USA
Adela Fernández-Ortega
Institut Català d' Oncologia L'Hospitalet (ICO) L'Hospitalet, Barcelona, Spain
Vicente Carañana
Department of Medical Oncology, Hospital Arnau de Vilanova, Valencia, Spain
Sonia Servitja
Hospital del Mar, Barcelona, Spain
Ander Urruticoechea
Gipuzkoa Cancer Unit- Osakidetza/Biodonostia, San Sebastián, Spain
Laura Lema-Roso
Hospital Universitario 12 de Octubre, Madrid, Spain
Antonia Márquez
UGCI Oncología Médica, Hospital Universitario Regional y Virgen de la Victoria, IBIMA, Málaga, Spain
Alexandros Lazaris
Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey, USA
Daniel Alcalá-López
Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey, USA
Leonardo Mina
Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey, USA
Petra Gener
Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey, USA
Jose Rodríguez-Morató
Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey, USA
Gabriele Antonarelli
Department of Oncology and Haemato-Oncology (DIPO), University of Milan, Milan, Italy; Division of Early Drug Development for Innovative Therapy, European Institute of Oncology, IRCCS, Milan, Italy
Antonio Llombart-Cussac
Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey, USA; Department of Medical Oncology, Hospital Arnau de Vilanova, Valencia, Spain; Corresponding author. Department of Medical Oncology, Hospital Arnau de Vilanova, Valencia, Spain.
José Pérez-García
Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey, USA; International Breast Cancer Center (IBCC), Pangaea Oncology, Quiron Group, Barcelona, Spain
Javier Cortés
Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey, USA; International Breast Cancer Center (IBCC), Pangaea Oncology, Quiron Group, Barcelona, Spain; Universidad Europea de Madrid, Faculty of Biomedical and Health Sciences, Department of Medicine, Madrid, Spain
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.
