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Clinical Trial
. 2024 Dec:78:103834.
doi: 10.1016/j.breast.2024.103834. Epub 2024 Nov 3.

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  1 , Elena López-Miranda  2 , Adela Fernández-Ortega  3 , Vicente Carañana  4 , Sonia Servitja  5 , Ander Urruticoechea  6 , Laura Lema-Roso  7 , Antonia Márquez  8 , Alexandros Lazaris  9 , Daniel Alcalá-López  9 , Leonardo Mina  9 , Petra Gener  9 , Jose Rodríguez-Morató  9 , Gabriele Antonarelli  10 , Antonio Llombart-Cussac  11 , José Pérez-García  12 , Javier Cortés  13
Affiliations
Clinical Trial

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 et al. Breast. 2024 Dec.

Abstract

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.

Keywords: Germline BRCA1/2 mutations; Homologous recombination deficiency; Olaparib; PARP inhibitors; Triple-negative breast cancer.

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Conflict of interest statement

Declaration of competing interest AC declares consulting or advisory role (GSK, AZ, Pfizer, and Daiichi Sankyo), speaker's bureau (GSK, AZ, MSD, Clovis, and Accord), research funding (Pfizer, and GSK), travel expenses (Daiichi Sankyo, and Pfizer), and other relationships (Co-founder ONCAR). EL-M declares consultant or advisory board role (Roche, AstraZeneca, and Daiichi Sankyo), and travel expenses (Roche, and Gilead). SS declares speakers' bureau (Daiichi-Sankyo, AstraZeneca, RocheO, and Novartis), advisory board role (Seagen, Genomic Health, MSD, and Daiichi-Sankyo) and travel expenses (Daiichi-Sankyo). AL, DA-L, LM, PG, and JR-M declare to be employees at Medica Scientia Innovation Research (MEDSIR). GA declares honoraria from Medica Scientia Innovation Research (MEDSIR). AL-C declares research support (Roche, Agendia, Lilly, Pfizer, Novartis, Merck Sharp & Dohme, Gilead, and Daichii-Sanyo), consulting or advisory role (Lilly, Roche, Pfizer, and Novartis). speakers’ bureaus (Lilly, AstraZeneca, and Merck Sharp & Dohme), travel expenses (Roche, Pfizer, and AstraZeneca), and stock or other ownership (MEDSIR and Initia-Research). JP-G declares advisory role (Lilly, Roche, Eisai, Daichii Sankyo, AstraZeneca, Seattle Genetics, and Gilead). travel expenses (Roche) and employment (MEDSIR). JC declares consulting or advisory role (Roche, Celgene, Cellestia, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Merck Sharp&Dohme, GSK, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Ellipses, Hibercell, BioInvent, Gemoab, Gilead, Menarini, Zymeworks, Reveal Genomics, Expres2ion Biotechnologies), honoraria (Roche, Novartis, Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, Merck Sharp&Dohme, Daiichi Sankyo, Astrazeneca), research funding to the Institution (Roche, Ariad pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer healthcare, Eisai, F. Hoffman-La Roche, Guardanth health, Merck Sharp&Dohme, Pfizer, Piqur Therapeutics, Puma C, Queen Mary University of London), Stock (MedSIR, Nektar Pharmaceuticals, Leuko [relative]), Travel, accommodation, expenses (Roche, Novartis, Eisai, Pfizer, Daiichi Sankyo, AstraZeneca, Gilead), and patents (Pharmaceutical Combinations of A Pi3k Inhibitor And A Microtubule Destabilizing Agent. Javier Cortés Castán, Alejandro Piris Giménez, Violeta Serra Elizalde. WO 2014/199294 A. ISSUED; Her2 as a predictor of response to dual HER2 blockade in the absence of cytotoxic therapy. Aleix Prat, Antonio Llombart, Javier Cortés.US 2019/0338368 A1_LICENSED). AF-O, VC, AU, LL-R, and AM declare no conflicts of interests.

Figures

Fig. 1
Fig. 1
Patient disposition.
See this image and copyright information in PMC

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