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

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

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.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / therapeutic use
  • BRCA1 Protein / genetics
  • BRCA2 Protein / genetics
  • Female
  • Germ-Line Mutation*
  • Homologous Recombination
  • Humans
  • Middle Aged
  • Phthalazines* / therapeutic use
  • Piperazines* / therapeutic use
  • Poly(ADP-ribose) Polymerase Inhibitors / therapeutic use
  • Treatment Outcome
  • Triple Negative Breast Neoplasms* / drug therapy
  • Triple Negative Breast Neoplasms* / genetics

Substances

  • Phthalazines
  • olaparib
  • Piperazines
  • Poly(ADP-ribose) Polymerase Inhibitors
  • BRCA1 Protein
  • BRCA1 protein, human
  • BRCA2 Protein
  • Antineoplastic Agents
  • BRCA2 protein, human

Associated data

  • ClinicalTrials.gov/NCT03367689