Schorndorf

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 evaluating how well insulin icodec helps people with type 1 diabetes control their blood sugar levels. This study focuses on participants who have never used insulin icodec before and aims to observe their treatment experience over a period of about 22 to 30 weeks. The study is designed as a real-world, multi-center, prospective observational study to assess glycemic control, treatment satisfaction, and adherence. Participants will be treated with commercially available insulin icodec as prescribed by their doctors, following usual clinical practice. There is no randomization or placebo group; all participants receive insulin icodec. The treatment period lasts approximately 22 to 30 weeks, during which participants continue their daily basal and bolus insulin regimen prior to starting insulin icodec. During the study, participants will have their blood sugar control monitored, including measuring changes in glycated hemoglobin (HbA1c) from baseline to week 26. Researchers will also assess treatment satisfaction and adherence. Participants must provide consent and be available for study visits and data recording throughout the study duration.

Researchers are investigating the real-world use, effectiveness, quality of life impact, safety, and tolerability of the combination of encorafenib and binimetinib in patients with unresectable advanced or metastatic melanoma that has a specific BRAF V600 mutation. This prospective, longitudinal, non-interventional study focuses on patients in Germany, Austria, and Switzerland who receive these drugs after they became commercially available. The study includes patients receiving first or second line treatment, particularly after prior checkpoint inhibitor therapy. The study observes patients treated with encorafenib plus binimetinib according to approved prescribing guidelines (Summary of Product Characteristics). Patients may have started treatment within six months before joining the study or plan to start soon. No experimental interventions are given; instead, the study collects real-life treatment data under routine clinical care in multiple centers across the three countries. Participants will be followed to gather information on progression-free survival at 12 months after starting treatment. Data collected include safety, tolerability, quality of life, and treatment patterns. The study documents patient outcomes and treatment experiences in a naturalistic setting without altering standard care. Participation duration depends on treatment and follow-up schedules determined by routine clinical practice and study timelines.

Researchers are studying metastatic colorectal carcinoma (mCRC) patients whose tumors have a BRAFV600E mutation, which is known to have a poorer outlook compared to non-mutated cases. Standard treatments after the first therapy have shown limited success, with low response rates and short survival times. This study aims to understand how the combination of encorafenib and cetuximab works in real-world settings, focusing on effectiveness, quality of life, safety, and tolerability in German, Austrian, and Swiss patients who have already received prior therapies. Participants will receive encorafenib combined with cetuximab, treatments that target specific cancer mutations. This study is observational and non-interventional, meaning it records how patients respond to these drugs in routine care without altering their treatment. The study allows initial retrospective data collection and will follow patients longitudinally to gather comprehensive information about their experiences with the therapy. During the study, patients will be monitored for overall survival twelve months after starting treatment. Researchers will assess how well the treatment controls the cancer, side effects experienced, and patients' quality of life. Data will be collected from medical records and patient reports in regular clinical care, providing insights into the real-life use and impact of encorafenib and cetuximab for this patient group.

Researchers are evaluating the real-world effectiveness of durvalumab-based treatments in patients with hepatobiliary cancers, including unresectable hepatocellular carcinoma (uHCC) and advanced biliary tract cancers (aBTC). This multicountry, multicenter observational study aims to collect contemporary data on these treatments across 22 countries, involving approximately 2500 adult patients. The study focuses on measuring overall survival and other clinical outcomes in routine clinical practice or through early access programs. The study collects data on patients treated with durvalumab-based regimens, including combinations such as STRIDE (Single Tremelimumab Regular Interval Durvalumab) and durvalumab with chemotherapy (e.g., Durvalumab plus GemCis). Data collection includes primary data gathered during routine visits and secondary data from medical records at enrollment and every 6 months. The study includes a baseline period of up to 5 years before starting durvalumab treatment and follows patients for up to 2 years for aBTC and 3 years for uHCC. Participants will have their demographics, clinical characteristics, treatment patterns, concomitant medications, and key outcomes such as real-world overall survival assessed at multiple time points (6, 12, 24 months for both aBTC and uHCC, and 36 months for uHCC). Researchers will also monitor progression-free survival, time to treatment progression, recurrence-free survival, and other clinical endpoints. Safety and follow-up continue until death, loss to follow-up, withdrawal, or study end.