Furstenwalde Spree

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 depemokimab as a treatment for adults aged 40 to 80 years with moderate to severe chronic obstructive pulmonary disease (COPD) who have type 2 inflammation and frequent exacerbations. This Phase 3 study aims to assess the safety and effectiveness of depemokimab when added to optimized inhaler therapy compared to placebo in participants whose COPD is uncontrolled despite current treatment. Participants must have an elevated blood eosinophil count and a history of COPD symptoms and exacerbations. Participants will receive depemokimab, a sterile liquid drug, or a placebo consisting of a sterile 0.9% sodium chloride solution. The treatments are administered as an add-on to their usual inhaler therapies, which include inhaled corticosteroids, long-acting muscarinic antagonists, and long-acting beta2-adrenergic agonists. The study is randomized, double-blind, placebo-controlled, and takes place across multiple centers. Treatment duration and detailed dosing schedules are not specified but participants are monitored up to 104 weeks. Throughout the study, participants will be monitored for the annual rate of moderate to severe COPD exacerbations. Researchers will also assess safety and other clinical outcomes related to lung function and COPD symptoms. Participants will have regular visits for evaluation of their disease status, treatment adherence, and any side effects. The total duration of participation includes baseline screening and follow-up visits over the study period to ensure comprehensive data collection for efficacy and safety analysis.

This research aims to explore the role of Digital Navigators (DN) in helping general practitioners, outpatient psychiatrists, psychologists, and their patients use digital mental health apps (DiGAs) and incorporate them into treatment. The study focuses on understanding the acceptance, expectations, and potential benefits of Digital Navigators, including their impact on patients' psychological health, digital health literacy, and technical skills. It targets patients with mental disorders who have access to smartphones and basic digital skills. Trained medical team members, primarily medical assistants, become Digital Navigators through a specialized training program adapted from Harvard Medical School. These Digital Navigators support treatment teams in selecting and integrating suitable digital health applications and assist patients over a 12-week period to find and use appropriate mental health apps. The intervention includes guidance through the DiGAnavigator.de website and ongoing support to enhance adherence and ease the burden on healthcare providers. Participants undergo assessments before and after the 12-week support period, measuring digital health literacy focused on information retrieval and interactive skills, as well as attitudes and expectations toward Digital Navigators. Researchers also evaluate implementation challenges and the effects on patients and professionals using standardized scales. The study includes interviews, focus groups, and surveys to capture digital skills, willingness to change, and illness severity. The goal is to establish sustainable training for Digital Navigators in mental health care.

Researchers are evaluating whether adding elacestrant, an oral selective estrogen receptor degrader (SERD), to standard olaparib therapy improves progression-free survival in patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer who have gBRCA1/2 mutations. This phase II, multi-center, randomized, open-label study addresses the urgent need for better treatments in this patient group, who typically have low progression-free survival. Elacestrant has been approved for certain breast cancers resistant to endocrine therapy, and olaparib is an approved PARP inhibitor for gBRCA-mutated metastatic breast cancer. Participants will be randomly assigned in a 2:1 ratio to one of two treatment groups: Arm A receives 600 mg olaparib plus 400 mg elacestrant daily, while Arm B receives 600 mg olaparib daily alone. Treatment continues until disease progression, unacceptable side effects, patient withdrawal, or study completion. Blood tests are done at the start of each treatment cycle, and tumor imaging as well as quality of life assessments are conducted every three months or when progression is suspected. During the study, participants will undergo regular blood tests and imaging scans to monitor tumor status and safety. Quality of life questionnaires will also be used to assess patient well-being. Researchers will measure progression-free survival up to 48 months from randomization, defined as time until disease progression or death. The study includes ongoing safety monitoring and follow-up until the end of the study period.

Researchers are studying both early and advanced/metastatic breast cancer to improve therapy decisions and healthcare quality. Metastatic breast cancer patients often have the poorest prognosis, and there is a need to better understand tumor characteristics to guide targeted therapies. This study aims to establish methods for analyzing molecular features of tumors and metastases using blood samples, as tumor biopsies can be invasive and are not routinely performed despite recommendations. Participants will have blood samples taken during routine blood draws to analyze tumor expression, mutations, gene copy number changes, and other molecular markers. The study focuses on creating a comprehensive infrastructure for molecular assessment in breast cancer patients at different stages. The research also explores healthcare outcomes and economics to enhance patient integration and awareness. Participants will be monitored to discover biomarkers that predict progression-free survival in metastatic breast cancer and assess disease-free survival in early breast cancer over up to 60 months. The study involves routine clinical assessments and blood collections, with data collected on tumor characteristics and patient health outcomes. Overall participation spans long-term follow-up to evaluate progression and survival measures.

Researchers are evaluating the patient-reported outcomes, real-world efficacy, and safety of trastuzumab deruxtecan (T-DXd) in patients with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer receiving treatment according to the approved product guidelines in routine clinical practice in Germany. This prospective, non-interventional, multicenter study includes approximately 800 patients divided equally into HER2-positive and HER2-low/ultralow groups. Patients will also be informed about the use of a digital healthcare application (DiGA). Eligible patients must be receiving T-DXd as part of their routine care, with all diagnostic tests and treatment visits determined by their treating physicians and not by the study protocol. The study observes patients treated with T-DXd in line with the applicable summary of product characteristics. Treatment decisions, including visit frequency and procedures, follow standard clinical practice rather than study-mandated schedules. Participants will be followed to monitor the time from the first dose of T-DXd until the start of the next treatment or death, assessed for up to 60 months. Data collection will include patient-reported outcomes, safety information, and real-world clinical data. The study aims to gather comprehensive information on treatment effects and patient experiences during routine care without altering their treatment plan.

Researchers are evaluating the long-term effects of Dupilumab treatment on patients with Chronic Obstructive Pulmonary Disease (COPD) in a real-world setting over 24 months. The study focuses on changes in health-related quality of life, patient characteristics, effectiveness, and safety of Dupilumab for those whose COPD remains uncontrolled despite standard therapies and who have elevated blood eosinophils. This is a non-interventional study where patients receive Dupilumab as prescribed by their doctors according to approved guidelines, without any treatment administered by the study itself. Dupilumab treatment initiation happens independently from study recruitment, and patient data is collected during routine clinical care. Participants will be involved for up to 12 months with assessments including monitoring changes in the COPD Assessment Test (CAT) score from baseline. Data is gathered through clinical evaluations and patient-reported outcomes. Safety and effectiveness are observed through regular documentation of clinical health and patient experiences during their ongoing treatment.