To date, 6 patients have successfully been randomized in the LUZERN study, reaching 100% recruitment in Stage I. We would like to thank all the study teams for their interest and commitment to the study.
LUZERN is focused on ER+/ HER2-, locally advanced or metastatic breast cancer patients harboring either germline BRCA (gBRCA) mutations or wild type BRCA with homologous recombination deficiency (HRD). Patients will be treated with Niraparib (PARP inhibitor) in combination with aromatase inhibitors to evaluate the efficacy and safety of this strategy.
The primary objective is to assess 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 secondary objective is to assess efficacy –as determined by the Progression-free Survival (PFS), Objective Response Rate (ORR), time to response (TTR), duration of response (DoR), overall survival (OS), and maximum tumor reduction– of niraparib in combination with AIs in these patients. Also to evaluate the safety and tolerability of niraparib in combination with AIs in these patients.
A total of 23 patients will be recruited in the study in cohort A and Cohort B as follows:
• Stage I: N=6 patients in the cohort A (Patients with documented germinal mutation in BRCA1 or BRCA2 genes that is predicted to be deleterious or suspected deleterious)
Currenty stage I is closed and we are waiting for the results.
• Stage II: N=8 patients in the cohort A; N=9 patients in the exploratory cohort B (Patients with either germinal BRCA1/2 wild-type (gBRCAwt) or gBRCAms that are considered to be non detrimental and homologous recombination deficiency (HRD).