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Found 3 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
Researchers are evaluating the effects of stopping CDK4/6 inhibitors in women with metastatic hormone receptor-positive, HER2-negative breast cancer who have had long-lasting disease control. This phase II, low-intervention trial aims to assess whether patients can maintain stable disease after discontinuing CDK4/6 inhibitors following at least 12 months of combined treatment with endocrine therapy. The study focuses on long-term disease stabilization and progression-free survival 12 months after randomization. Participants are assigned to either continue or discontinue CDK4/6 inhibitors such as Palbociclib or Abemaciclib while maintaining endocrine therapy. The study is open-label and multicenter, allowing close observation of treatment effects. During the trial, patients will be monitored to see if disease control persists after stopping the CDK4/6 inhibitor treatment. Throughout the study, participants undergo regular assessments including evaluations of disease status and safety monitoring. Researchers will track progression-free survival at 12 months after randomization as the primary outcome. The trial includes detailed monitoring of participants' health and treatment responses to understand the impact of discontinuing CDK4/6 inhibitors in this patient population.
Actively Recruiting
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.