Russelsheim Am Main

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 AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

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.

Atrial fibrillation is the most common heart rhythm disorder, increasing the risk of blood clots forming in the heart, especially in the left atrium. These clots can cause strokes if they travel to the brain. Patients with atrial fibrillation who have had an intracranial bleed bleeding in the brain are often treated with blood thinners to prevent stroke, but these medications can increase bleeding risk. This study compares two treatment methods to prevent strokes in such patients blood thinners and a device that closes off the left atrial appendage of the heart. The study randomly assigns participants to one of two groups. One group receives a device called Watchman or Watchman FLX to close the left atrial appendage through a minimally invasive procedure, followed by short-term blood thinning medication. The other group receives standard oral blood thinners as per current guidelines. Only approved drugs and devices are used. The trial aims to provide data to help doctors manage patients with atrial fibrillation who have experienced brain bleeds. Participants are followed for up to three years after randomization. Researchers monitor for events such as death from cardiovascular causes, stroke, systemic embolism, and bleeding episodes. Assessments include imaging during the procedure and regular follow-up visits to track health outcomes. The main measure is event-free survival without these complications. This long-term follow-up helps evaluate the safety and effectiveness of each treatment approach in preventing strokes and bleeding.

This research aims to determine the best duration of blood-thinning medication after elective total hip arthroplasty THA to prevent blood clots. The study compares a shorter 10-day course versus the standard 35-day course of anticoagulation after hip replacement surgery. It focuses on patients eligible for early mobilization and evaluates whether the shorter treatment is as effective at preventing dangerous clots within 90 days after surgery. The trial randomly assigns patients to one of two groups one receiving the anticoagulant rivaroxaban from day 3 to day 10 post-surgery followed by placebo until day 35, and the other receiving rivaroxaban continuously for 35 days. Both groups follow a standard enhanced recovery protocol with early mobilization after surgery. This double-blind study includes an initial two-day open-label anticoagulation period before randomization. Participants will have follow-up visits on day 35 and day 90 after surgery to monitor for blood clots, bleeding events, and overall recovery. Researchers will assess outcomes including symptomatic deep vein thrombosis, pulmonary embolism, hospital stay length, joint function, and quality of life. Safety and any adverse events will be closely tracked during these visits to understand the benefits and risks of shorter anticoagulation treatment after hip replacement.

Researchers are collecting real-world data in Germany to better understand how patients with non-squamous metastatic non-small cell lung cancer NSQ mNSCLC, including certain cases of large cell neuroendocrine carcinoma, respond to a combination of tremelimumab, durvalumab, and platinum-based chemotherapy TDC. The study focuses on the effectiveness of this treatment in relation to specific genetic mutations and protein expressions such as KRAS, STK11, KEAP1, TP53, TTF-1, and PD-L1. This observational study aims to improve knowledge about biomarker-guided treatment strategies for distinct patient subgroups with high medical needs. The study follows patients who are starting first-line treatment with TDC as prescribed by current marketing authorizations. Researchers will observe and record outcomes without altering the treatment plan. The study includes molecular testing such as Next Generation Sequencing for gene mutations and protein expression analyses initiated according to institutional standards. Women who can become pregnant must use effective contraception during and for three months after durvalumab treatment. Participants will be monitored over time for up to two years to assess overall survival rates, treatment responses, progression-free survival, and safety through adverse event collection. Data will be gathered from routine clinical practice visits and medical records. The main measurement is the two-year overall survival rate in the total population and in subgroups with specific gene mutations. This study helps track how well treatments work and their safety in everyday medical settings.

This research investigates GLSI-100 immunotherapy in people with HER2neu positive breast cancer who are at high risk for their cancer returning. It focuses on participants who have completed both neoadjuvant and postoperative adjuvant standard treatments. The study is Phase 3, randomized, double-blinded, and placebo-controlled, involving subjects who are HLA-A*02 positive as well as an open-label group of non-HLA-A*02 positive subjects. The goal is to evaluate the treatments impact on invasive breast cancer-free survival over a median follow-up of 4 years. Participants receive 6 primary immunization injections of GLSI-100 or placebo intradermally once a month for the first 6 months, followed by 5 booster injections spaced 6 months apart, totaling 11 injections over 3 years. There are three groups one receiving placebo 0.9% normal saline, one receiving GLSI-100 immunotherapy in HLA-A*02 positive subjects, and an open-label arm for non-HLA-A*02 positive subjects receiving GLSI-100 under the same schedule. During the study, participants undergo regular monitoring and assessments including invasive disease-free survival, distant disease-free survival, overall survival, and quality of life questionnaires at baseline and up to 36 months. Researchers track safety and treatment effects over a median 4-year follow-up. The study continues until December 2031, aiming to provide comprehensive data on long-term outcomes and quality of life for participants receiving these treatments.

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 evaluating the effectiveness and safety of a subcutaneous treatment using one cycle of cladribine for patients with hairy cell leukemia who need treatment. This study focuses on patients who are either untreated or have been previously treated only with alpha-interferon. The goal is to determine the rate of complete remission and to assess whether a second cycle of treatment benefits those with a non-optimal response, defined as detectable residual disease or partial remission four months after the initial treatment. Participants receive cladribine at a dose of 0.14 mgkg body weight administered subcutaneously as a bolus injection once daily for five consecutive days. After four months, remission status is evaluated. Patients showing non-optimal response may be considered for a second treatment cycle. This phase 23 trial is designed to optimize therapy for hairy cell leukemia by closely monitoring treatment response and toxicity. During the study, participants undergo evaluations including disease status assessment through bone marrow and blood tests, with a focus on remission rates four months post-treatment. Researchers track complete remission rates and monitor for residual disease. Safety is also monitored by assessing potential toxicities. Participants general health status and other laboratory tests are reviewed to ensure eligibility and ongoing suitability for treatment throughout the study period, which spans several months with follow-up assessments.