Element (GBG 114)


This is a Phase II, prospective, multi-center, randomized, open label, parallel group study evaluating the impact on PFS of elacestrant with niraparib compared to niraparib alone in patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with g/tBRCA1/2 and/or g/tPALB2 mutations. A total of 176 patients in Germany will be included in the study. The detection of a tumor/germline mutation in BRCA1/2 and/or PALB2 is a prerequisite for screening for the study.



The study is currently in the process of selecting the trial centers (= feasibility).



The inclusion and exclusion criteria as well as more detailed information on the study design are available on request.



Project management

Jana Roßney


+496102 / 7480-440