Niraparib Plus Aromatase Inhibitors for Luminal-like(HER2-,ER+) and gBRCA or HDR+ Metastatic Breast Cancer (LUZERN)
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
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 100 mg and the study dose will be 200mg or 300mg daily
continuously in 28-day cycles plus aromatase Inhibitors.
Total study duration is 36 months and until 5 years of follow up.