Zittau

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.

Immune thrombocytopenia (ITP) is a rare blood disorder where the immune system causes a shortage of platelets, leading to increased bleeding risk. New treatment options have emerged recently, but clinical studies often focus on specific patient groups. This research collects real-world data from a broad range of ITP patients to better understand the diagnosis, treatment, and outcomes in everyday care. The study also aims to improve personalized therapy and patient results by gathering detailed clinical and biospecimen information. The study involves creating a national registry where clinical data and biospecimens are collected from patients diagnosed with primary or secondary ITP. Data are gathered prospectively at defined points during the disease course, and patients can also be included retrospectively within 12 months of diagnosis if ongoing documentation is available. This includes information about disease factors, treatment types, complications, quality of life, fatigue, and survival over 5 years. Participants will provide written consent and undergo clinical assessments at enrollment and follow-up visits. Researchers will collect epidemiological data such as disease incidence, age and sex distribution, causes, treatment types, and remission status over 5 years. The registry also includes biospecimen collection to support high-quality, standardized research. This ongoing monitoring will help improve knowledge of ITP and support better patient care.

Researchers are evaluating the patient-reported outcomes, real-world efficacy, and safety of trastuzumab deruxtecan (T-DXd) in patients with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer receiving treatment according to the approved product guidelines in routine clinical practice in Germany. This prospective, non-interventional, multicenter study includes approximately 800 patients divided equally into HER2-positive and HER2-low/ultralow groups. Patients will also be informed about the use of a digital healthcare application (DiGA). Eligible patients must be receiving T-DXd as part of their routine care, with all diagnostic tests and treatment visits determined by their treating physicians and not by the study protocol. The study observes patients treated with T-DXd in line with the applicable summary of product characteristics. Treatment decisions, including visit frequency and procedures, follow standard clinical practice rather than study-mandated schedules. Participants will be followed to monitor the time from the first dose of T-DXd until the start of the next treatment or death, assessed for up to 60 months. Data collection will include patient-reported outcomes, safety information, and real-world clinical data. The study aims to gather comprehensive information on treatment effects and patient experiences during routine care without altering their treatment plan.