Bautzen

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 conducting a prospective, multicenter, open-label randomized controlled trial to compare early catheter-directed treatment combined with conventional care versus conventional care alone in patients with high-risk pulmonary embolism. This trial focuses on patients with acute massive pulmonary embolism who have a high risk of mortality as defined by specific European Society of Cardiology (ESC) guidelines. The primary goal is to evaluate outcomes related to mortality, recurrent cardiac arrest, or persistent shock within 7 days. Participants randomized to the early catheter-interventional treatment group will undergo catheter-directed therapy within 60 minutes of randomization. This treatment may involve the use of certified devices such as aspiration thrombectomy, local fibrinolytic therapy, or ultrasound-assisted fibrinolysis, administered via transfemoral venous access. Sheaths used during the procedure are typically removed immediately after thrombectomy or 5 to 10 hours following local fibrinolysis. The comparator group will receive conventional reperfusion treatment. Preparations for fibrinolytic therapy are made in parallel to ensure timely administration if needed. During the study, participants will be closely monitored for clinical outcomes related to survival, cardiac arrest, and shock within the first week. Assessments include imaging studies such as CT angiograms and echocardiograms to confirm pulmonary embolism status and right-ventricular function. Safety and effectiveness are evaluated through this observation period. The study includes adults aged 18 years and older and excludes those with contraindications to catheter-based or fibrinolytic treatments, as well as pregnant individuals. Total study duration and follow-up details are not specified.

Researchers are evaluating real-world clinical data in women with primary advanced (FIGO stage III or IV) or recurrent endometrial cancer who are receiving first-line treatment with Carboplatin, Paclitaxel, and Durvalumab (CPD). The study focuses on patients treated with CPD followed by maintenance therapy using either durvalumab alone or durvalumab combined with olaparib. This multi-center, prospective, non-interventional study aims to understand the effectiveness, safety, and patient-reported outcomes of these treatments in routine clinical practice in Germany. Participants receive first-line CPD chemotherapy after surgery and/or radiation if applicable. Following this, maintenance therapy is given with durvalumab for patients with DNA mismatch repair deficient tumors (dMMR cohort) or with durvalumab plus olaparib for those with DNA mismatch repair proficient tumors (pMMR cohort). Treatment decisions are made jointly by patients and their physicians as part of standard care, independent of the study itself. During the study, data on treatment effectiveness and safety will be collected along with patient-reported outcomes after the chemotherapy phase. Researchers will monitor real-world time to the next treatment over 12 months. Patients will complete questionnaires and their tumor mismatch repair status must be known. The study includes women aged 18 years or older and involves regular follow-ups to gather comprehensive information about the treatment effects and patient experience.