To date, 4 patients have successfully been randomized in the LUZERN study, reaching 75% recruitment in Stage I. In order to complete 100% of recruitment and close Stage I of this study we need to randomize 2 more patients.
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 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 second objective is to assess the 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.
Exploratory objectives include; to assess the prevalence of gBRCAms and HRD in these
patients, to evaluate predictive and/or prognostic biomarkers associated with disease activity status or patient outcomes for the combination of niraparib and AIs in these patients, and to identify possible mechanisms of resistance to the combination of niraparib and AIs through the comparative analysis of potential biomarkers from paired pre-treatment and post-progression tumor biopsies and/or blood samples 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)
• 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 nondetrimental and homologous recombination deficiency (HRD).
We would like to thank the study teams for their interest and commitment to the LUZERN study. Together we can do more!
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