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
{"title":"奥拉帕利单药治疗同源重组缺陷且无 BRCA1/2 基因突变的晚期三阴性乳腺癌患者：NOBROLA 2 期研究。","authors":"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","doi":"10.1016/j.breast.2024.103834","DOIUrl":null,"url":null,"abstract":"<div><h3>Purpose</h3><div>To evaluate olaparib in advanced triple negative breast cancer (TNBC) patients with homologous recombination deficiency (HRD) and no germline <em>BRCA1/2</em> mutations (g<em>BRCA1/2</em>mut).</div></div><div><h3>Methods</h3><div>NOBROLA (NCT03367689) is a single-arm, open-label, multicenter, phase IIa trial, enrolling adult patients with advanced TNBC without <em>gBRCA1/2mut</em> and with HRD, who were treated with olaparib. The primary endpoint was clinical benefit rate (CBR) per RECIST v.1.1.</div></div><div><h3>Results</h3><div>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).</div></div><div><h3>Conclusions</h3><div>The observed results could prompt further investigation.</div></div><div><h3>Trial</h3><div>ClinicalTrials.gov identifier NCT03367689.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"78 ","pages":"Article 103834"},"PeriodicalIF":5.7000,"publicationDate":"2024-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"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\",\"doi\":\"10.1016/j.breast.2024.103834\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Purpose</h3><div>To evaluate olaparib in advanced triple negative breast cancer (TNBC) patients with homologous recombination deficiency (HRD) and no germline <em>BRCA1/2</em> mutations (g<em>BRCA1/2</em>mut).</div></div><div><h3>Methods</h3><div>NOBROLA (NCT03367689) is a single-arm, open-label, multicenter, phase IIa trial, enrolling adult patients with advanced TNBC without <em>gBRCA1/2mut</em> and with HRD, who were treated with olaparib. The primary endpoint was clinical benefit rate (CBR) per RECIST v.1.1.</div></div><div><h3>Results</h3><div>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).</div></div><div><h3>Conclusions</h3><div>The observed results could prompt further investigation.</div></div><div><h3>Trial</h3><div>ClinicalTrials.gov identifier NCT03367689.</div></div>\",\"PeriodicalId\":9093,\"journal\":{\"name\":\"Breast\",\"volume\":\"78 \",\"pages\":\"Article 103834\"},\"PeriodicalIF\":5.7000,\"publicationDate\":\"2024-11-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Breast\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0960977624001656\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Breast","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0960977624001656","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
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 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.
期刊介绍：
The Breast is an international, multidisciplinary journal for researchers and clinicians, which focuses on translational and clinical research for the advancement of breast cancer prevention, diagnosis and treatment of all stages.
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