Friedrichshafen

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 addition of Tersolisib LY4064809STX-478 to other anti-cancer drugs as a first treatment for adults with advanced hormone receptor-positive HRhuman epidermal growth factor receptor 2-negative HER2- breast cancer that has a PIK3CA mutation. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand the efficacy and safety of this combination compared to placebo, focusing on improving outcomes for patients with this specific genetic change. Participants receive LY4064809 orally in one of two doses combined with a CDK46 inhibitor such as Ribociclib, Palbociclib, or Abemaciclib and endocrine therapy ET administered orally or via intramuscular injection. The comparison group receives a placebo combined with the same CDK46 inhibitor and ET. The study includes two parts Part 1 explores dose optimization, and Part 2 evaluates the treatment combinations effectiveness and safety as a first-line therapy. During the study, participants will have regular assessments to monitor cancer response, progression, and safety over an estimated period of up to 5 years or more. Researchers will measure outcomes such as overall response rate, progression-free survival, duration of response, overall survival, and quality of life. Treatment continues as long as the cancer benefits without intolerable side effects. Safety monitoring, laboratory tests, and quality of life questionnaires are part of the participant involvement throughout the trial.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are evaluating the safety, effectiveness, and quality of life for combining Abemaciclib with either an Aromatase Inhibitor or Fulvestrant in women with metastatic hormone receptor-positive, HER2-negative breast cancer. This Phase IV trial focuses on both pre- and postmenopausal patients receiving first-line treatment. A digital health app called CANKADO will be used to track side effects and patient-reported outcomes daily, alongside standard documentation. The study also aims to explore biomarkers to better understand treatment responses and resistance. Participants will receive either Abemaciclib combined with an Aromatase Inhibitor Anastrozole, Letrozole, or Exemestane taken orally twice daily plus daily Aromatase Inhibitor tablets every 24 hours in 28-day cycles, or Abemaciclib with Fulvestrant which is given as an injection on specific days within 28-day cycles. The two treatment groups are experimental and non-randomized, with no masking. The trial includes monitoring for side effects and quality of life throughout treatment. During the study, participants will regularly report side effects and global health status using questionnaires at multiple time points up to 24 months, including specialized breast cancer quality of life modules. Researchers will assess progression-free survival up to 48 months, as well as adverse events, hospitalizations, clinical benefit rate, overall survival, and tumor response. The use of the CANKADO app for side effect reporting is strongly recommended but not mandatory. Participants will be followed for safety and outcomes throughout the trial duration.

Researchers are investigating the effects of stopping CDK46 inhibitors in women with metastatic hormone receptor HR positive, HER2 negative breast cancer who have maintained disease control after long-term treatment. This phase II trial aims to evaluate whether disease stability continues when CDK46 inhibitors are discontinued after at least 12 months of combined treatment with endocrine therapy. The study is open-label, randomized, and conducted at multiple centers. Participants are randomly assigned to one of two groups one group continues both CDK46 inhibitor treatment such as Palbociclib or Abemaciclib and endocrine therapy, while the other group discontinues the CDK46 inhibitor but continues endocrine therapy alone. The study monitors disease progression and treatment effects over time, with a focus on how long patients remain free from disease worsening after stopping the CDK46 inhibitor. During the study, participants will be regularly assessed for disease progression, safety, and quality of life using questionnaires and clinical evaluations. Researchers will measure progression-free survival at 12 months and up to 54 months, time to treatment failure, time to first chemotherapy use, and monitor adverse events. The total participation duration may extend beyond four years, with ongoing evaluations to understand long-term outcomes and safety after stopping the CDK46 inhibitor.

Researchers are evaluating the long-term safety of Deucravacitinib compared to Ustekinumab in adults with moderate-to-severe plaque psoriasis. This Phase 3b4 study focuses on cardiovascular events and other health outcomes over an extended period, aiming to understand how these treatments impact patients with psoriasis who have cardiovascular risk factors. The study is led by Bristol-Myers Squibb and involves random assignment of participants to either treatment. Participants receive either Deucravacitinib or Ustekinumab at specified doses on scheduled days. The study is open-label, meaning both participants and researchers know which treatment is being given. This trial runs for up to 5 years, during which patients are monitored for cardiovascular safety and other health events related to their psoriasis treatment. Throughout the study, participants undergo regular assessments to track major cardiovascular events like heart attacks, strokes, and hospitalizations, as well as monitoring for infections, cancer, and treatment side effects. Researchers collect data on liver function and lipid levels up to 60 days after the last dose. The long-term follow-up helps evaluate safety and health outcomes over several years, with study activities continuing until early 2031.

Patients with atrial fibrillation who undergo percutaneous coronary intervention PCI with stent implantation need different antithrombotic drugs to prevent stroke and heart complications. Current standard treatment includes three antithrombotic drugs for 1 week to 1 month, then two drugs for 6 to 12 months, followed by long-term treatment with one anticoagulant. Researchers are studying whether a single drug approach can reduce bleeding while still protecting against clotting events in a large trial of 3,010 patients. This study compares two treatment plans. One group takes a P2Y12 inhibitor alone for 1 month after stent placement, then switches to a direct-acting oral anticoagulant DOAC alone for 11 months. The other group follows standard care triple therapy aspirin, P2Y12 inhibitor, DOAC for up to 1 month, dual therapy P2Y12 inhibitor and DOAC for 6 to 12 months, and then DOAC alone. The study is randomized, open-label, and conducted across multiple sites internationally. Participants are monitored over 12 months with assessments of major cardiac or cerebral events like death, heart attack, stroke, and systemic embolism, as well as bleeding complications. Researchers will track hospitalizations, revascularizations, and detailed bleeding events using established criteria. After the study, patients receive routine care. The trial aims to find a safer, effective antithrombotic approach for atrial fibrillation patients after stent implantation.

Researchers are collecting data to evaluate the safety, performance, and clinical benefits of BIOTRONIKs electrophysiology EP products used in patients with cardiac arrhythmias. This observational, international study aims to support regulatory requirements and maintain approval for these devices in the European CE region by monitoring risks during and after procedures. Participants will undergo diagnostic or therapeutic catheter interventions using BIOTRONIK EP products, which include catheters, external devices like RF generators and pacemakers, and transseptal sheaths. These devices are used temporarily during electrophysiology studies or catheter ablation procedures. The study does not involve randomization or blinding and follows patients through their routine care. During the study, researchers will collect data on device deficiencies and adverse effects during the EP procedure, within 24 hours afterward, and up to 3 to 6 months post-procedure. Clinical benefits will be confirmed at the time of the procedure. Participants are expected to attend follow-up visits at the study site, and data collection will continue until mid-2030 to assess device safety and performance over time.

Researchers are evaluating the safety and performance of RefluxStop2, a device used in the treatment of Gastroesophageal Reflux Disease GERD. This post-market registry study focuses on patients receiving standard care procedures to better understand how RefluxStop performs in general hospital practice. The study is sponsored by Implantica CE Reflux Ltd. and tracks outcomes over several years. Participants will be treated with either the RefluxStop device implantation using a standard surgical technique or undergo the standard of care Nissen fundoplication surgery for GERD. Both interventions are observed under typical clinical conditions. The study includes follow-up periods at 3, 6 months, and annually up to 5 years to monitor both safety and performance. During the study, participants will have regular assessments including pH monitoring and hernia evaluations. Researchers will track the position of the RefluxStop device and measure reflux symptoms using specific safety and performance endpoints at 3 and 6 months, and then yearly for up to 5 years. The total duration of participation varies, with key outcome measurements focused on the first 6 months and long-term follow-up ongoing.

Researchers are conducting a multicenter observational study to follow up on patients with severe tricuspid regurgitation who have been treated with the TricValve4 Transcatheter Bicaval Valves System. This study aims to monitor the long-term outcomes and health status of these patients after receiving this specific valve treatment. It includes patients who have undergone this procedure and focuses on assessing their heart function and related complications over time. Participants in the study have already been treated with the TricValve device in both the Inferior Vena Cava and Superior Vena Cava. The study involves a follow-up period lasting up to five years, with scheduled clinical visits at discharge, 1 month, 6 months, 1 year, and annually thereafter up to 5 years. During these visits, routine tests such as blood counts, kidney function tests, electrocardiograms, and echocardiograms are performed to evaluate the valves function and the hearts hemodynamic status. Throughout the follow-up, researchers will track important health outcomes, including hospital readmissions for heart failure, mortality rates, adverse events, changes in heart function and valve performance, and patient functional status using the New York Heart Association NYHA classification. The study will also assess biomarkers related to heart function and medication adjustments. These comprehensive evaluations help researchers understand the safety and durability of the TricValve system over time.