Westerstede

Researchers are evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who experience agitation related to Alzheimers Disease. This Phase 3 study aims to understand how these medications impact agitation symptoms in this population, using recognized criteria to confirm Alzheimers diagnosis and agitation severity. Participants will be randomly assigned to receive either the combination of KarXT and KarX-EC or a placebo. Dosing is specified for certain days, and the study includes a 14-week treatment period during which agitation and other symptoms will be closely monitored. The study design includes a quadruple-blind method to reduce bias. During the study, participants and their caregivers will attend regular visits where the researchers will assess changes in agitation using tools like the Cohen-Mansfield Agitation Inventory and Clinical Global Impressions-Severity scale. Safety will also be carefully monitored through various assessments including vital signs, lab tests, ECGs, and movement scales. Participant involvement extends up to 18 weeks to capture any adverse events and treatment effects.

This research aims to evaluate the long-term efficacy and safety of a combined formulation of xanomeline tartratetrospium chloride in an immediate release capsule KarXT and xanomeline enteric capsules KarX-EC for treating agitation in participants with Alzheimers Disease. The study focuses on individuals who have completed prior parent studies CN012-0023 or CN012-0024 and seeks to understand treatment effects over an extended period. Participants will receive specified doses of KarXT and KarX-EC on designated days as part of this single-group, non-randomized study. The treatment phase lasts up to approximately 30 weeks, during which the combined drugs are administered and monitored for safety and effectiveness related to agitation management in Alzheimers Disease. Throughout the study, participants will be monitored for treatment-emergent adverse events and other safety measures. Assessments include tracking adverse events, serious adverse events, changes in vital signs, laboratory evaluations, electrocardiograms, cognitive function tests like the Mini-mental State Examination and ADAS-Cog-13, as well as symptom severity scales. Caregiver involvement is required to provide support and facilitate study participation. The total study duration extends up to about 30 weeks with ongoing safety and efficacy evaluations.

Researchers are evaluating the safety and effectiveness of BGB-16673 compared to pirtobrutinib in adults with relapsed or refractory chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL who have previously been treated with a covalent Bruton tyrosine kinase inhibitor cBTKi. The study is a phase 3, open-label, randomized trial sponsored by BeOne Medicines, aiming to assess treatment options for these patients. Participants are randomly assigned to receive either BGB-16673 or pirtobrutinib, both taken orally. This parallel assignment design compares these two drugs directly. The treatments continue with monitoring up to approximately three years to observe progression-free survival and other outcomes. The study began in September 2025 and is expected to complete in April 2028. During the trial, participants will undergo regular assessments including imaging scans to measure disease status, quality of life questionnaires, and monitoring for adverse events. Outcomes such as overall survival, response rates, duration of response, and time to next treatment are tracked. Safety and quality of life will be evaluated throughout the study period, which may last up to about three years for each participant.

Researchers are conducting a Phase 2 study to assess the safety and effectiveness of a drug called MEDI0618 compared to a placebo in adults with episodic migraine. The study includes participants who have not responded to at least two different small molecule migraine preventive treatments and are either eligible but have not used aCGRP therapies or have previously failed one or more aCGRP preventive treatments. This research aims to improve migraine prevention options for these individuals. Participants will receive subcutaneous injections of MEDI0618 or placebo in a double-blind, randomized design. The study has multiple dosing arms including Dose A and three additional doses for the group not previously treated with aCGRP therapies, with participants assigned in a 11 ratio to either active drug or placebo. A separate group who have failed aCGRP therapies will also be randomized 11 to receive MEDI0618 or placebo. The treatment period includes repeated dosing and evaluation of the drugs impact on migraine occurrence. Throughout the study, participants will be monitored for migraine headache days and the severity and disability caused by migraines from baseline through treatment. Evaluations will occur regularly from Day 1 to Day 141, including assessments focusing on migraine frequency between Weeks 9 and 12. Safety and efficacy will be closely observed in a controlled setting, and the study is expected to conclude in May 2027.

This research aims to assess the physical impact of Multiple Sclerosis MS from the participants perspective. It also provides participants continued access to the medication ocrelizumab while evaluating its safety and tolerability. The study is an open-label extension phase 3 trial sponsored by Hoffmann-La Roche, focusing on patients previously enrolled in related studies who currently lack local access to ocrelizumab treatment. Participants will receive ocrelizumab either as a 600 mg intravenous infusion or a 920 mg subcutaneous injection, following the dosing schedule established in their prior parent study. Treatment will continue until local access to the drug becomes available, if safety concerns arise, if the participant withdraws consent, or in the event of death. During the study, participants will be monitored for changes in physical functioning using patient-reported outcome measures over up to five years. Researchers will also track the number of participants receiving ocrelizumab and monitor adverse events, including serious or special interest events that may lead to discontinuation. Safety and tolerability assessments will continue throughout the study duration, which may last up to five years.

Researchers are investigating ribociclib combined with standard endocrine therapy for women with advanced hormone receptor-positive HR and HER2-negative breast cancer receiving first-line treatment. This phase IV, open-label study aims to understand how ribociclib works over time and identify patterns of resistance. The study also focuses on survival rates at 12 months and includes a comprehensive program to discover and validate biomarkers related to treatment outcomes. Participants will receive ribociclib once daily for 21 days followed by 7 days off, in 28-day cycles, alongside standard endocrine therapy prescribed by their doctors. The treatment follows the approved guidelines Summary of Product Characteristics for ribociclib. This trial plans to enroll 1000 female patients across 75 sites in Germany and involves extensive biomarker sampling from blood, tissue, and immune cells before, during, and after treatment or disease progression. During the study, participants will have regular assessments including survival monitoring at various time points up to 36 months, quality of life evaluations, and safety checks for treatment-related side effects. Samples for biomarker research will be collected to help understand treatment response. Follow-up includes collecting data on progression-free and overall survival, quality of life, and adverse events, with total study involvement lasting up to 36 months.

Researchers are observing the real-world effects and patient experiences of trastuzumab deruxtecan T-DXd treatment in adults with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer. This prospective, non-interventional study takes place in multiple centers in Germany and aims to collect patient-reported outcomes along with safety and efficacy data during routine clinical practice. Approximately 800 patients will be enrolled, divided evenly between HER2-positive and HER2-lowultralow cohorts. Participants will receive T-DXd treatment as prescribed by their doctors according to the approved product guidelines SmPC. Treatment and visit schedules are determined by the treating physician and are not fixed by the study protocol. Patients will also be informed about using a digital healthcare application DiGA during the study. The study includes two cohorts based on HER2 status, both receiving T-DXd in routine care. During the study, participants will be followed to measure the time until their next treatment or death, assessed for up to 60 months from the first T-DXd dose. Quality of life will be evaluated using questionnaires at six months after baseline. Patient safety and treatment effects will be monitored through data collected in routine clinical visits. The total participation period may extend up to eight years, allowing for long-term observation of treatment outcomes in real-world settings.

Researchers are conducting a prospective, observational study to describe the real-world clinical experience of patients with metastatic castration-resistant prostate cancer mCRPC treated with a combination of olaparib and abiraterone. The study aims to assess clinical outcomes in patients who are either new to novel hormonal agents NHA-naive or have been previously exposed to these agents before starting olaparib plus abiraterone treatment. Patient demographics, clinical characteristics, and treatments before and after olaparib plus abiraterone will also be documented. Participants will be observed from the start of their olaparib plus abiraterone treatment, with no investigational interventions administered by the study team, reflecting real-world treatment usage. The study plans to enroll patients for up to two years and will follow each patient for one year after the last patient begins treatment. The primary outcome measured is the time to treatment discontinuation within 12 months, along with secondary outcomes such as the time to the first subsequent therapy within 24 months. During the study, participants clinical data, treatment histories, and outcomes will be collected and analyzed. There are no specific study visits or procedures imposed beyond routine clinical care. Safety and treatment adherence will be monitored through observational data. Participants are expected to be involved for the duration of their treatment and follow-up, which may extend to approximately three years from enrollment start to last follow-up.

Researchers are studying how well cabozantinib works and how safe it is for adults with neuroendocrine tumors NETs, a type of cancer that can develop in various parts of the body. All participants have previously received at least one systemic treatment for their cancer, but their disease has continued to progress. This observational study takes place in regular hospitals and clinics in Germany and Austria, involving about 150 participants. Participants receive cabozantinib as part of their usual medical care, without any extra tests or procedures beyond routine clinical practice. Doctors collect data from regular medical visits, scans, and tests to monitor how the cancer responds to treatment and how long participants stay on cabozantinib. The study also observes side effects and assesses quality of life using questionnaires over time. Throughout the study, participants undergo evaluations including scans and laboratory tests at baseline and every three months for up to 18 months. Researchers track outcomes such as disease control rate at 6 months, progression-free survival, treatment duration, side effects, and quality of life changes. The study follows participants until the end of 2028 to gather comprehensive information on the treatment course and patient experiences.