Friedrichshafen

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 the effectiveness and safety of adding Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as the first treatment for adults with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This phase 3 study focuses on participants whose cancer has a specific genetic change called a PIK3CA mutation and who have not received prior treatment for advanced breast cancer. The study aims to understand how well this treatment combination works and its safety over time. Participants will receive Tersolisib or a placebo, combined with a CDK4/6 inhibitor (Ribociclib, Palbociclib, or Abemaciclib) and endocrine therapy (Anastrozole, Letrozole, Exemestane, or Fulvestrant). All drugs are given orally except for Fulvestrant, which is given by injection into the muscle. The study includes two parts: Part 1 allows participants who have had up to two prior treatments for advanced breast cancer, including chemotherapy; Part 2 includes those with no prior treatment for advanced disease and classifies them as endocrine sensitive or resistant based on their cancer history. During the study, participants will be regularly assessed for cancer response, progression-free survival, and side effects. Researchers will monitor measurable disease or bone involvement and track overall response rates, including complete or partial tumor shrinkage. The study will continue as long as the treatment is helping without causing unbearable side effects. Follow-up may last up to five years to observe long-term outcomes and safety.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are evaluating the safety, effectiveness, and quality of life for combining Abemaciclib with either an Aromatase Inhibitor or Fulvestrant in women with hormone receptor positive, HER2 negative metastatic breast cancer. This includes both premenopausal and postmenopausal patients receiving first-line treatment. The trial also explores biomarker research to understand responses and resistance to this combined endocrine therapy. Participants receive Abemaciclib 150 mg orally every 12 hours along with either an Aromatase Inhibitor (Anastrozole, Letrozole, or Exemestane) taken once daily in 28-day cycles, or Fulvestrant given by injection on days 1 and 15 of the first cycle, then on day 1 of subsequent 28-day cycles. Side effects and patient-reported outcomes are monitored using the CANKADO digital health app, allowing daily tracking alongside standard clinical documentation. During the study, patients regularly report symptoms and side effects through the app, and undergo laboratory tests, imaging, and clinical assessments to monitor disease progression and treatment safety. The main outcome measured is progression-free survival over up to 48 months. Safety and quality of life are also closely observed throughout the trial period.

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.

Researchers are evaluating the long-term safety of two drugs, Deucravacitinib and Ustekinumab, in adults with moderate-to-severe plaque psoriasis. This Phase 3b/4 study focuses on participants who are candidates for phototherapy or systemic treatment and have specific cardiovascular risk factors such as smoking, hypertension, diabetes, obesity, or a family history of heart disease. Participants will receive either Deucravacitinib or Ustekinumab at specified doses on set days. This open-label, randomized study compares these treatments over an extended period to monitor their safety profiles, including cardiovascular health. Throughout the study, researchers will track major adverse cardiovascular events, including heart attacks, strokes, and related procedures, for up to five years. Participants will undergo regular assessments to monitor their psoriasis and cardiovascular status, ensuring comprehensive safety evaluation during the long-term treatment.

This research investigates the best antithrombotic treatment for patients with atrial fibrillation who have undergone percutaneous coronary intervention (PCI) with stent implantation. These patients need oral anticoagulants to reduce stroke risk and antiplatelet drugs to prevent heart problems like heart attacks or stent blockage. The study aims to find out if using just one antithrombotic drug at a time can reduce bleeding risks while still protecting against clots compared to the current standard combination therapy. It is a phase 4, international, randomized trial involving 3010 patients across Europe and Brazil. Participants will be randomly assigned to one of two treatment groups. One group will receive a single antithrombotic drug: a P2Y12 inhibitor for one month followed by a direct oral anticoagulant (DOAC) for 11 months. The other group will receive the standard care of triple therapy (aspirin, P2Y12 inhibitor, and DOAC) for up to one month, then dual therapy (P2Y12 inhibitor plus DOAC) for 6 to 12 months, and then DOAC alone thereafter. The choice of specific P2Y12 inhibitors and DOACs is left to the doctors' discretion. During the 12-month follow-up, researchers will monitor participants for major heart or brain-related events, including death, heart attacks, strokes, or embolism, as well as serious or clinically relevant bleeding. The study involves close evaluation of safety and effectiveness through regular assessments, with the goal of finding a treatment strategy that balances bleeding risk and protection against clotting events in this high-risk population.

This research aims to gather data on the safety, performance, and clinical benefits of BIOTRONIK's electrophysiology (EP) products used in patients with cardiac arrhythmias. The study is a prospective, observational, multi-center, international, open-label, and non-randomized trial designed to support regulatory post-market clinical follow-up requirements and maintain approval of these products in the CE region. Residual and newly emerging risks associated with the devices will also be monitored throughout the study. Participants will undergo diagnostic or therapeutic catheter interventions using BIOTRONIK EP catheters, external devices such as RF generators and pacemakers, and transseptal sheaths. These devices are intended for temporary transvenous use during electrophysiology studies or catheter ablation procedures. The study collects data during and after these procedures, including the rate of device deficiencies, peri-procedural and post-procedural adverse effects, and confirmation of clinical benefits at the time of the procedure. Throughout the study, participants will be monitored during the procedure and followed up to 3 to 6 months afterward. Researchers will record safety and performance outcomes such as device-related adverse effects and clinical benefit confirmations. Participants are expected to attend all follow-up visits at the study site and provide informed consent. The total participation duration spans from the procedure through the follow-up period to ensure comprehensive data collection and safety monitoring.

Researchers are evaluating the safety and performance of RefluxStop10 in treating Gastroesophageal Reflux Disease (GERD) through this post-market registry study. The study focuses on patients with documented GERD lasting more than six months, aiming to observe the device's impact during standard care procedures. Participants will receive either the RefluxStop device implanted using a standard surgical technique or the established Nissen fundoplication surgery as a comparison. Both procedures are performed under general anesthesia, following standard hospital practices for GERD treatment. The study observes patients over a six-month period to assess safety and performance outcomes. Throughout the study, participants will be monitored for primary safety and effectiveness endpoints at six months. This includes assessments related to the treatment's impact on GERD symptoms and any adverse effects. The study involves regular follow-ups and evaluations typical for patients undergoing these surgical procedures, ensuring careful tracking of health status and treatment response.

Researchers are conducting a multicenter clinical follow-up study on patients with severe tricuspid regurgitation who have been treated with the TricValve4 Transcatheter Bicaval Valves System. This observational study aims to monitor the long-term outcomes of these patients, focusing on heart failure and valve function. The study includes patients who have already received this treatment and meets specific inclusion criteria. Participants in this study were treated with the TricValve4 device placed in the Inferior Vena Cava and Superior Vena Cava. The study follows patients for up to five years, with scheduled clinical consultations at discharge, 1 month, 6 months, 1 year, and annually up to 5 years after their procedure. During these visits, routine exams such as blood counts, kidney function tests, electrocardiograms, and echocardiography are performed to assess the valve's performance and heart function. Throughout the study, researchers will monitor patients' health status, including any hospital readmissions for heart failure within 12 months. The follow-up includes documentation of bioprosthesis functioning and hemodynamic profiles to understand better the long-term effects of the treatment. Participants will be observed over several years to gather comprehensive clinical data about their condition and treatment outcomes.