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

• Published in: Breast (Edinburgh) Vol. 78; p. 103834
• Main Authors: Cortés, Alfonso, López-Miranda, Elena, Fernández-Ortega, Adela, Carañana, Vicente, Servitja, Sonia, Urruticoechea, Ander, Lema-Roso, Laura, Márquez, Antonia, Lazaris, Alexandros, Alcalá-López, Daniel, Mina, Leonardo, Gener, Petra, Rodríguez-Morató, Jose, Antonarelli, Gabriele, Llombart-Cussac, Antonio, Pérez-García, José, Cortés, Javier
• Format: Journal Article
• Language: English
• Published: Elsevier Ltd 01-12-2024; Elsevier
• Subjects: Germline BRCA1/2 mutations; Homologous recombination deficiency; Olaparib; PARP inhibitors; Short Communication; Triple-negative breast cancer; Olaparib; Germline BRCA1/2 mutations; Homologous recombination deficiency; PARP inhibitors; Triple-negative breast cancer
• ISSN: 0960-9776; 1532-3080; 1532-3080
• DOI: 10.1016/j.breast.2024.103834

To evaluate olaparib in advanced triple negative breast cancer (TNBC) patients with homologous recombination deficiency (HRD) and no germline BRCA1/2 mutations (gBRCA1/2mut).
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.
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).
The observed results could prompt further investigation.
ClinicalTrials.gov identifier NCT03367689.
•TNBC is a heterogenous disease with poor prognosis and limited therapeutic options.•Olaparib was approved for HER2-negative advanced BC patients with gBRCA1/2mut.•Out of 114 patients screened, only 6 were eligible and received olaparib.•Olaparib showed 50 % of CBR and ORR in advanced TNBC patients with HRD and without gBRCA1/2mut.•The patient population was low, and the results warrant further investigation in larger trials.