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。

IF 5.7 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Breast Pub Date : 2024-11-03 DOI:10.1016/j.breast.2024.103834

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

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引用次数: 0

摘要

目的：评估奥拉帕利对同源重组缺陷（HRD）且无种系BRCA1/2突变（gBRCA1/2mut）的晚期三阴性乳腺癌（TNBC）患者的治疗效果：NOBROLA（NCT03367689）是一项单臂、开放标签、多中心、IIa期试验，纳入了接受奥拉帕利治疗的无gBRCA1/2突变且伴有HRD的晚期TNBC成年患者。主要终点是RECIST v.1.1规定的临床获益率（CBR）：114例患者中有6例符合条件并接受了奥拉帕尼治疗。中位随访时间为 8.5 个月。CBR和总体应答率（ORR）均为50%（95% CI，11.8-88.2）：结论：观察到的结果可能会促使进一步的研究：试验：ClinicalTrials.gov 标识符 NCT03367689。

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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.

Trial

ClinicalTrials.gov identifier NCT03367689.

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来源期刊

Breast 医学-妇产科学

CiteScore

8.70

自引率

2.60%

发文量

165

审稿时长

59 days

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.