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.

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.

SUBMITTER: Cortes A 

PROVIDER: S-EPMC11585816 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature