Troisdorf

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 safety and effectiveness of the study drug IPN10200 compared with a placebo for treating adults with Cervical Dystonia (CD). CD causes abnormal movements and symptoms in the head and neck, including pain, stiffness, and headaches. The condition may be influenced by brain function, genetics, and environmental factors. Current treatments involve botulinum toxin (BoNT) injections lasting about three months, but IPN10200 is designed to provide longer-lasting relief. Participants will receive a single intramuscular injection of IPN10200 at one of several doses or a placebo on the first day of the 36-week treatment period. The injections will be given into muscles in the head, neck, and shoulders. Before treatment, there is a screening period lasting up to four weeks to confirm eligibility. Some participants may continue other medications during the study, with all treatments recorded. The study involves about 40 weeks of participation, including screening and treatment. Participants will attend 10 to 12 in-person clinic visits plus one remote phone visit. During these visits, they will undergo blood and urine tests, physical and neurological exams, and clinical assessments. Questionnaires will also be completed to evaluate symptoms and treatment effects. The main outcome measured is the change in cervical dystonia severity four weeks after treatment based on a standardized rating scale.

This research aims to evaluate the effectiveness of trastuzumab deruxtecan (T-DXd) in adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have previously been treated with a trastuzumab-based regimen. The study also collects patient demographic and clinical information, treatment patterns, and safety data including serious adverse events and drug reactions. It includes a disease registry for patients receiving conventional therapies in a real-world European setting. The study is non-interventional, meaning no investigational drugs are administered beyond standard care. Patients receiving T-DXd will be treated according to the Summary of Product Characteristics (SmPC), and data on conventional therapies such as platinum-fluoropyrimidine chemotherapy, nivolumab, ramucirumab-paclitaxel, taxane, irinotecan, and pembrolizumab will also be gathered. Treatment choices and administration follow the physician's decision and routine clinical practice. Participants will be monitored from baseline to about two years to assess the time to next treatment. Researchers will collect clinical data, treatment details, tolerability, and patient surveys to understand outcomes and safety. The study involves regular follow-up and data collection to track treatment effectiveness and patient experience in real-world settings.

Researchers are evaluating the safety and effectiveness of increasing doses of IPN10200 to understand its pharmacodynamics and identify the best dose for treating adults with upper limb spasticity. This integrated Phase I/II, multicenter, double-blind, randomized study also compares IPN10200 with Dysport and placebo to find the optimal balance of efficacy and safety in adults aged 18 to 70 years with spastic hemiparesis following stroke or traumatic brain injury. Participants receive either IPN10200, Dysport, or placebo as a powder and solvent solution for injection. The study includes dose escalation and dose-finding phases to assess different dosing levels. Treatments are administered in the affected upper limb muscles, with eligibility based on specific muscle tone and spasticity angle criteria. The study monitors participants for up to 9 months, including a safety follow-up period. During the study, participants undergo regular assessments including vital signs (blood pressure and heart rate), clinical lab tests, physical examinations, and monitoring for treatment-emergent adverse events and antibodies to the study drugs. Researchers use these measures to evaluate safety and treatment effects over the 9-month period from baseline through the end of the study.

Researchers are evaluating the use, benefits, and safety of cemiplimab-based treatment regimens for adults with advanced non-small cell lung cancer (NSCLC). This observational study focuses on patients prescribed cemiplimab as part of routine care in Europe. The study aims to gather real-world information on how cemiplimab is used and how it affects patient outcomes. Participants receive cemiplimab, given by intravenous infusion, often combined with platinum-based chemotherapy, also administered intravenously. Data collection occurs during regular clinical visits approximately every three months while patients are on cemiplimab treatment. After treatment ends, follow-up visits occur about every six months for up to two years. The recruitment phase will last 48 months. Participants will be followed from the start of cemiplimab treatment until death, loss to follow-up, withdrawal, or up to 72 months after the study begins. During the study, researchers will collect information from routine visits and questionnaires. The primary outcome measured is overall survival up to 72 months. Safety and effectiveness of the treatment regimen will be monitored throughout the study period.

Researchers are studying metastatic colorectal carcinoma (mCRC) patients whose tumors have a BRAFV600E mutation, which is known to have a poorer outlook compared to non-mutated cases. Standard treatments after the first therapy have shown limited success, with low response rates and short survival times. This study aims to understand how the combination of encorafenib and cetuximab works in real-world settings, focusing on effectiveness, quality of life, safety, and tolerability in German, Austrian, and Swiss patients who have already received prior therapies. Participants will receive encorafenib combined with cetuximab, treatments that target specific cancer mutations. This study is observational and non-interventional, meaning it records how patients respond to these drugs in routine care without altering their treatment. The study allows initial retrospective data collection and will follow patients longitudinally to gather comprehensive information about their experiences with the therapy. During the study, patients will be monitored for overall survival twelve months after starting treatment. Researchers will assess how well the treatment controls the cancer, side effects experienced, and patients' quality of life. Data will be collected from medical records and patient reports in regular clinical care, providing insights into the real-life use and impact of encorafenib and cetuximab for this patient group.

Researchers are evaluating the effectiveness of capivasertib combined with fulvestrant compared to fulvestrant alone as a neoadjuvant treatment for women with primary high-risk lobular breast cancer that is hormone receptor-positive and HER2-negative. This phase II, multicenter, prospective, open-label, randomized study focuses on measuring complete cell cycle arrest (CCCA), defined by a drop in Ki67 below 2.7% from baseline to week 2 and week 10. The study aims to identify patients who may benefit from chemotherapy sparing and to better understand treatment responses in this specific breast cancer subtype. Participants are randomly assigned to receive either capivasertib plus fulvestrant or fulvestrant alone. The capivasertib group takes 400 mg orally twice daily for four days followed by three days off, repeated for two weeks, then continues this dosing alongside fulvestrant injections (500 mg intramuscularly every 28 days, with an additional dose two weeks after the initial) for eight more weeks. The fulvestrant-only group receives the same injection schedule for ten weeks. Treatment continues until surgery or core biopsy, disease progression, unacceptable side effects, or patient withdrawal. All patients undergo core biopsies during treatment to assess Ki67 levels. Following study treatment, further therapies such as surgery, chemotherapy, radiotherapy, or endocrine therapy are given based on standard care and investigator discretion. Participants will have multiple evaluations including core biopsies to monitor Ki67, laboratory tests, and cardiac assessments. Safety and treatment effects are centrally reviewed by a pathologist who is blinded to the treatment assignment. The main outcome measured is complete cell cycle arrest within 14 weeks. Patients are closely monitored for side effects and disease status throughout the study. The total study duration involves treatment for up to ten weeks with follow-up as per standard clinical care.

Researchers are investigating the use of ribociclib combined with standard endocrine therapy as a first-line treatment for women with advanced hormone receptor positive (HR+) and human epidermal growth factor receptor negative (HER2-) breast cancer. This phase IV, open-label, single-arm study aims to evaluate the progression-free survival (PFS) and overall survival (OS) rates at 12 months, along with quality of life, treatment toxicity, and comprehensive biomarker analysis to understand patterns of treatment efficacy and resistance. Participants will receive ribociclib orally at a dose of 600 mg daily for 21 consecutive days followed by 7 days off, in 28-day cycles, combined with standard endocrine therapy according to current guidelines and local practice. The study includes extensive biomarker sampling before, during, and after treatment or at disease progression, including blood, tissue, and immune cell analyses to support translational research. During the trial, patients will attend scheduled visits for monitoring and assessments including survival status, safety evaluations, and quality of life questionnaires. Biomarker samples such as circulating tumor DNA and RNA, serum, plasma, and tumor tissue will be collected to evaluate biological changes. The trial plans to enroll 1000 female patients across 75 sites in Germany, with comprehensive follow-up to track treatment outcomes and long-term safety.

Researchers are investigating treatments for triple-negative breast cancer (TNBC), a type of breast cancer known for its aggressive nature, poor prognosis, and diverse molecular characteristics. This study focuses on patients with early-stage, lower-risk TNBC, particularly those with stage I-II node-negative disease, who generally have better outcomes but still face significant clinical challenges. The trial aims to compare the effects of sacituzumab govitecan alone versus sacituzumab govitecan combined with pembrolizumab in this patient group, seeking to improve treatment responses and survival rates. Participants will receive sacituzumab govitecan at a dose of 10 mg/kg administered twice on days 1 and 8 within a 21-day cycle. Some participants will also receive pembrolizumab at 200 mg every three weeks. The study evaluates treatment durations between 12 and 18 weeks in the neoadjuvant (pre-surgery) setting. The purpose is to assess whether these regimens can produce comparable pathological complete remission rates with a better safety profile compared to standard chemotherapy. The combination with pembrolizumab is explored based on promising results in more advanced TNBC stages. Throughout the study, participants will undergo various assessments including imaging, pathology reviews, and laboratory tests to monitor tumor response and overall health. The primary outcomes measured are pathological complete remission at surgery and invasive disease-free survival rate after three years. Safety and tolerability will also be closely observed. Participants must comply with treatment schedules and follow-ups, providing consent and cooperating with all protocol requirements during the study period.

Researchers are evaluating treatments for patients with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) in a multinational, randomized, open-label phase II trial. The study compares an experimental approach using FDG-PET-based small volume accelerated radiotherapy combined with standard chemotherapy against a conventional approach using standard FDG-PET-based radiotherapy with the same chemotherapy. This trial aims to assess the completion rates and outcomes of these two chemoradiotherapy strategies followed by consolidation immunotherapy. Participants are randomly assigned 1:1 to receive either the experimental radiotherapy with concurrent chemotherapy or the conventional radiotherapy with concurrent chemotherapy. Those who achieve complete response, partial response, or stable disease after chemoradiotherapy will then receive consolidation therapy with durvalumab, given as a fixed dose every 4 weeks for up to 12 months or until disease progression, unacceptable side effects, or other reasons. After durvalumab treatment ends, patients undergo a 90-day safety follow-up and then survival follow-up lasting until 24 months after the last patient started durvalumab. Patients with disease progression post-chemoradiotherapy receive treatment as decided by investigators but will be followed until the study ends. Throughout the study, participants undergo tumor assessments by FDG-PET CT and lung function tests before treatment starts. Researchers monitor treatment completion rates about 22 weeks after starting chemoradiotherapy as the primary outcome. Safety and survival are closely followed after immunotherapy. The study includes laboratory tests, performance status evaluations, and ongoing monitoring to ensure participant safety and collect data on treatment effects over an extended period.