Official Title: Multicenter, open-label, phase II clinical trial to evaluate the efficacy and safety of niraparib plus aromatase inhibitors for hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancers with either germline BRCA-mutated or germinal BRCA-wild-type and homologous recombination deficiency (HRD) – The LUZERN Strategy.
The primary goal 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.Exploratory objectives:
- 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.
- 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.
LUZERN at clinicaltrials.gov