Furstenwalde Spree

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 depemokimab as a treatment for adults aged 40 to 80 with moderate to severe chronic obstructive pulmonary disease COPD who have type 2 inflammation and uncontrolled symptoms despite standard care. The study aims to assess the safety and effectiveness of depemokimab compared to a placebo when added to the usual treatment. This phase 3 trial is sponsored by GlaxoSmithKline and focuses on reducing COPD exacerbations and improving respiratory symptoms over a long period. Participants will receive either depemokimab by subcutaneous injection alongside their standard inhaler therapy or a placebo injection plus standard care. The study is randomized, double-blind, and includes two groups one receiving depemokimab and the other a placebo, both continuing optimized inhaler treatments. This study will last up to 104 weeks, with regular assessments throughout. During the study, participants will undergo evaluations including lung function tests, symptom questionnaires such as the COPD assessment test and St. Georges Respiratory Questionnaire, and monitoring for COPD flare-ups or hospital visits. Researchers will track the number and severity of exacerbations and changes in quality of life measures. Safety and tolerability will also be closely monitored throughout the trial duration, which extends up to two years.

Researchers are evaluating how Digital Navigators DN can assist general practitioners, outpatient psychiatrists, psychologists, and their patients in using digital mental health apps DiGAs and integrating them into treatment. The study aims to understand the opportunities and barriers to implementing DNs, acceptance and expectations towards them, and their effects on patients psychological health and digital literacy. Medical assistants and other medical team employees receive training to become Digital Navigators. These trained navigators support treatment teams in selecting and integrating suitable mental health apps and accompany patients for 12 weeks to help them find and use an appropriate app. The study includes a preliminary phase with interviews and focus groups, followed by DN training and a 12-week intervention period with 48 patients. Participants undergo assessments before and after the 12-week intervention to measure digital health literacy, acceptance and expectations of Digital Navigators, psychological health, and digital competence. Data collection involves interviews, focus groups, and validated scales to evaluate symptom severity and treatment effects. The study also evaluates implementation barriers and aims to establish accredited DN training for sustainable use.

Researchers are studying patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer who have gBRCA12 mutations. This study aims to evaluate whether adding elacestrant, a new oral estrogen receptor blocker, to the standard olaparib treatment can improve progression-free survival compared to olaparib alone. This is a phase II, multi-center, randomized, open-label study with patients assigned in a 21 ratio to two different treatment groups. Participants randomized to Arm A will receive 600 mg of olaparib daily plus 400 mg of elacestrant daily, while those in Arm B will receive 600 mg of olaparib daily alone. Treatment will continue until disease progression, unacceptable side effects, patient withdrawal, or the study ends. Pre- and perimenopausal women, as well as men, will also receive a GnRH analogue at least two weeks before treatment starts. Dose modifications are provided for managing specific side effects. During the study, blood tests will be done at the start of each treatment cycle, and imaging scans along with quality of life assessments will be performed every three months or if disease progression is suspected. Researchers will measure progression-free survival, overall survival, treatment failure times, response rates, clinical benefit, adverse events, and treatment compliance. Participants may remain in the study for up to 48 months, with an average treatment duration of about 12 months per patient.

Researchers are studying patients with breast cancer, focusing on those with metastatic disease who typically have the poorest outlook. The trial aims to improve treatment decisions and quality of care by analyzing tumor characteristics. Although national guidelines recommend molecular reassessment of metastatic tumors, biopsies are rare due to invasiveness, so the study explores blood-based methods to assess tumor features and their relation to treatment outcomes and health economics. The study involves two groups about 3,500 patients with locally advanced or metastatic breast cancer receiving any line of treatment, and approximately 10,000 patients with early breast cancer undergoing neoadjuvant or adjuvant therapy regardless of regimen. Blood samples will be collected during routine blood draws to analyze tumor molecular characteristics and biomarkers for progression and survival. Participants will be followed with assessments including quality of life, therapy adherence, depression factors, and adverse events at study entry and regularly up to 60 months. The study will measure progression-free survival in metastatic breast cancer and disease-free survival in early breast cancer, along with overall survival and health economic outcomes. Results of molecular testing will be shared with patients at study end, providing comprehensive data to support improved breast cancer care.

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 evaluating how Dupilumab affects health-related quality of life, patient characteristics, efficacy, and safety in adults with Chronic Obstructive Pulmonary Disease COPD in a real-world setting over 24 months. This non-interventional study observes patients who have started Dupilumab treatment independently of the study, focusing on those with uncontrolled COPD despite standard inhaled therapies and elevated blood eosinophils. Patients receive Dupilumab as prescribed in routine clinical practice, with no treatment assigned by the study itself. The study collects data over two years, documenting changes in COPD symptoms, lung function, exacerbation rates, and safety outcomes as patients continue their usual care. During the study, participants clinical data, including COPD Assessment Test CAT scores, lung function tests, exacerbation frequency, and adverse events, are monitored at regular intervals up to 24 months. Patient-reported outcomes and other health measures are collected to understand Dupilumabs long-term effects in everyday use. The study also gathers information on hospitalizations, workdays missed, and reasons for treatment initiation.