Gummersbach

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

Researchers are monitoring the long-term safety of efgartigimod, a biological treatment, in patients with generalized myasthenia gravis (gMG). This study is a non-interventional, prospective, post-authorization safety study designed to observe patients who are either starting or already receiving efgartigimod, as well as those with gMG who have not been treated with it. The study aims to compare the occurrence of serious infections and other safety outcomes over a period of up to 10 years. Patients with gMG who are expected to begin efgartigimod treatment at enrollment or who are currently in their first treatment cycle will be included in the efgartigimod group. Those with gMG who are not starting efgartigimod and have never received it will be enrolled in a non-efgartigimod group. There are no assigned treatments or interventions from the researchers; the study simply observes patients as they receive routine care. Participants will be followed for up to 10 years to track safety outcomes, including serious infections. Data collection will involve routine clinical assessments and monitoring as per standard medical practice. The study observes the real-world use of efgartigimod and its safety profile in managing gMG, providing valuable long-term information without altering patients' treatment plans.