Study design – main study
The SONIA study (BOOG 2017-03) is designed for women with advanced, hormone receptor positive breast cancer who will start palliative endocrine therapy. In our study, we try to answer the question of whén CDK4/6 inhibitors can best be added to endocrine therapy.
You can find the full study protocol on the website of BOOG study center.
Study design – side studies
In addition to the main study, several side studies have been set up. These side studies are optional: patients wo do not want to participate in these side studies, can still enroll in the main study.
Side study with extra blood tests
For this side study, we take additional blood samples at different time points throughout the course of the study. The samples will be analyzed for circulating tumor DNA and for pharmacodynamics and –genetics. Most blood samples will be taken at time points that require standard blood sampling, but for some (maximum of 2) moments an extra venipuncture is necessary.
You can find more information on this side study in the flowchart and the lab manuals; all documents can be accessed through the BOOG website.
Side study with extra imaging (SONImage)
For this side study, patients are asked to undergo one additional scan (a FES-PET-scan) before start of treatment. This scan can only take place in either the UMC Groningen or the Amsterdam UMC – location VUmc. Patients from different hospitals can be referred by their treating physician for participation in the study. The figure below depicts the study design.
Side study with extra cognitive testing (SONIA EfFECT)
For this side study, patients are asked to participate in two online neuropsychological evaluations. The first evaluation will take place at the beginning of the study, the other evaluation 9 months after study entry. When a patient provides informed consent for participation in the SONIA EfFECT side study, she will be contacted by the EfECT-researchers.
You can find more information on this side study in the SONIA EfFECT study manual, which can be accessed through the BOOG website.
You can include subjects directly through our online program (ALEA) or through the trial agency of IKNL (email@example.com). A filled out screening form and randomization form are necessary for signing up patients; both forms can be found on the website van of BOOG Study Center.