A Study on Improving Well-Being Through Individualized, Type-Based Patient Education During Therapy with an Aromatase Inhibitor and Ribociclib in Patients with Early-Stage Hormone Receptor-Positive and HER2-Negative Breast Cancer

Breast cancer is the most common cancer among women and can also occur in men. The majority of cases involve what are known as hormone receptor-positive (HR-positive) and HER2-negative tumors. This means that the growth of the cancer cells is promoted by sex hormones, while the growth factor receptor HER2 is not present in excessive amounts. Standard treatment following surgery often includes several years of anti-hormone therapy (endocrine therapy) to reduce the risk of recurrence. Recently, the drug ribociclib has also been approved for patients at high risk of recurrence. Ribociclib is a so-called CDK4/6 inhibitor that specifically interferes with the cell division cycle of cancer cells and stops their proliferation. The combination of ribociclib and an aromatase inhibitor (a drug that suppresses hormone production) has proven to be very effective. However, studies show that many patients discontinue therapy prematurely due to side effects or the burden of treatment, which can limit the treatment’s effectiveness.

The goal of the TYPER study is to improve treatment adherence (persistence) when taking ribociclib. To this end, a specialized coaching program is used that addresses how individual patients cope with their disease. Based on a questionnaire, patients are classified into four different types, depending on the extent to which they accept their disease and how much control they feel they have over its course. Each type receives a specific form of support—ranging from the provision of information alone to intensive personal counseling and emotional support. As part of the study, patients are randomly assigned to two groups. One group (the intervention arm) receives personalized coaching from trained professionals (TYPER coaches) in addition to standard medical care over a 12-month period. The other group (control arm) receives standard medical care without this specialized coaching. Both groups receive the same drug therapy consisting of ribociclib and an aromatase inhibitor. The study is open-label, meaning that both patients and medical staff know which group they have been assigned to. The primary endpoint of the study is the time to permanent discontinuation of ribociclib. In addition, quality of life, side effects, and long-term disease progression (e.g., relapse-free survival) are monitored. In addition, blood and tissue samples will be collected to identify potential biological markers (biomarkers) that could help predict treatment success or side effects.

Women and men aged 18 and older who have early-stage hormone receptor-positive, HER2-negative breast cancer and are scheduled to receive treatment with ribociclib and an aromatase inhibitor are eligible to participate in the study. The cancer must not have spread to other organs (no distant metastases).