Niraparib Plus Aromatase Inhibitors for Luminal-like(HER2-,ER+) and gBRCA or HDR+ Metastatic Breast Cancer (LUZERN)

Summary

This study evalues the efficacy -as determined by the clinical benefit rate (CBR)- of niraparib in combination with AIs in unresectable locally advanced or metastatic HR-positive/HER2-negative breast cancer patients harboring either gBRCAms or gBRCAwt and HRD. The planned number of patients is 23. Investigational product is Niraparib and will be administered daily continuously in 28-day cycles plus aromatase Inhibitors. Total study duration is 36 months and until 5 years of follow up.

Timeline

Start

2020-06-15

Primary completion

2022-11-17

Completion

2023-11-17

Drugs

Indications