Multicenter phase 2 trial of niraparib plus aromatase inhibitor for HR-positive HER2-negative advanced breast cancer with germline BRCA mutation

The multicenter phase 2 LUZERN trial in Spain evaluated the combination of niraparib plus an aromatase inhibitor (AI) for patients with previously AI-treated HR-positive/HER2-negative advanced breast cancer (aBC) with a germline BRCA1/2 mutation. The clinical benefit rate was 46.2% (95% CI 19.2-74.9), meeting the primary endpoint. Median progression-free survival was 5.5 months (9% CI 1.9-8.5) and median overall survival was 18.1 months (9.7-NE). The safety profile was consistent with the known toxicity profiles of the drugs. The authors conclude that the combination of niraparib plus an AI had encouraging antitumor activity with a manageable safety profile in patients with AI-resistant HR-positive/HER2-negative aBC with a germline BRCA1/2 mutation.