Clinical trials

Many patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer in the first therapy line is endocrine sensitive. For these patients the established 1st line standard therapy is a combination of a CDK4/6 inhibitor and an aromatase inhibitor. This combination therapy is usually given until clinical progression. Recent studies suggest that a detection of a somatic ESR1 mutation in the ctDNA can be clinically used to prompt an earlier change from the aromatase inhibitor to a selective estrogen receptor degrader. For implementation in the clinical routine it is important to gain knowledge about the dynamics of ESR1 mutation in HR+/HER2- advanced breast cancer patients during their first line therapy. At the beginning of the first line therapy about 5-8% of patients show an ESR1 mutation. An identification of patients with resistance to aromatase inhibitors at that timepoint might not be feasible and cost-efficient. At the timepoint of clinical progression up to 30-40% of patients will have acquired an ESR1 mutation. Knowledge about the mutation frequencies at different timepoints will be very helpful to direct testing strategies for implementing testing broadly in a population. The aim of this study is to test ESR1 mutation frequencies in groups of patients (single time test per patient) with no clinical progression and different durations under first-line treatment with aromatase inhibitor and CDK4/4 inhibitor.

The goal of this interventional study is to evaluate the effect of standardized patient coaching on treatment adherence among patients taking abemaciclib. The main question it aims to answer is, whether standardized coaching leads to patients taking abemaciclib much more consistently. Researchers will therefore compare therapy adherence of patients receiving standardized coaching to patients receiving routine care. Participants will be asked to answer several questionnaires.

The goal of this clinical trial is to evaluate the effect of patient education and patient typology-based coaching on therapy persistence in breast cancer patients taking ribociclib. Researchers will compare the time to permanent treatment discontinuation of patients receiving personalized coaching to the time to permanent treatment discontinuation of patients who only receive standard of care education and counselling, to see if adherence to treatment can be improved by personalized patient coaching.

The goal of this observational study is to evaluate how persistently patients with high-risk early breast cancer take abemaciclib 6 months after therapy start. To this end, researchers will perform a retrospective analysis of therapy data.

This is a single-arm, open-label phase IV study of patients with advanced HR+/HER2- breast cancer who are treated first line with ribociclib and standard of care endocrine treatment according to SmPC.