Muhlhausen Thuringen

This research aims to observe patients with relapsing multiple sclerosis RMS who are being treated with approved injectable or selected oral disease-modifying therapies DMTs in Germany. The study collects data to understand how these treatments are used in routine care and their effects over time. It is an observational, non-interventional, multicenter, open-label study sponsored by Novartis Pharmaceuticals. Patients will be followed in two cohorts Cohort 1 includes patients starting or recently started on injectable DMTs, and Cohort 2 includes patients starting or recently started on either ofatumumab or other approved injectable or oral DMTs. The core observational period is up to two years, with an optional extension adding another two years, totaling up to about four years of observation. Treatment decisions are made independently by patients and their physicians, and no study-mandated treatment or monitoring is imposed. Participants will provide data through questionnaires and electronic case report forms, with medical history including disease duration, lab values, MRI results, and relapse information collected. Routine clinical care assessments and telemedicine visits may occur at the investigators discretion. The study measures include treatment continuation rates, disability scores, relapse rates, quality of life, fatigue, anxiety, depression, MRI lesion monitoring, and safety events, with follow-up visits scheduled as per standard care over the study period.

Researchers are conducting a prospective, multicenter, observational study in Germany to evaluate the clinical value and impact of serum neurofilament light sNfL as a prognostic marker for disease activity in patients with relapsing Multiple Sclerosis MS. The study focuses on patients who have received category 1 disease-modifying therapies DMTs and monitors routinely assessed sNfL values to better understand their role in patient management. Participants in the study either continue their current category 1 DMT treatment or switch to ofatumumab based on their physicians clinical judgment, independent of study enrollment. Category 1 DMTs include medications such as dimethylfumarate, diroximelfumarate, glatiramer acetate, interferon beta, and teriflunomide. Data will be collected over a maximum period of 24 months during routine clinical visits, with no specific protocol dictating observation frequency or diagnostic procedures. During the study, researchers will gather primary data including sNfL test results and track various outcomes like disease activity, treatment adherence, patient-reported fatigue, quality of life, and treatment satisfaction. Assessments will align with standard care practices and guidelines, and the study will measure outcomes at baseline, 12 months, and 24 months. The study aims to provide insights into the use of sNfL in clinical practice and its implications for managing relapsing MS.

Researchers are studying the real-world effectiveness, safety, and patient experience 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 patient compliance and quality of life among those treated with ribociclib, abemaciclib with endocrine therapy, or endocrine therapy alone. The goal is to understand treatment decisions and how these therapies perform in routine care settings. Participants receive treatment as prescribed by their doctors based on local guidelines and product information for ribociclib plus aromatase inhibitor with or without LHRH, abemaciclib with endocrine therapy plus or minus LHRH, or endocrine therapy alone plus or minus LHRH. There is no random treatment assignment since this is an observational study. Baseline data are collected shortly before or after treatment initiation depending on the cohort. During the study, patients will be followed for up to 36 months to monitor invasive disease-free survival and other health outcomes. Researchers will collect information on adverse events, treatment modifications, adherence measures, quality of life questionnaires, and socio-economic factors at various timepoints. This will provide insights into treatment tolerability, patient compliance, and overall impact on quality of life in a real-world setting.

Researchers are studying patients with ER-positive, HER2-negative breast cancer who have experienced a relapse detected through circulating tumor DNA ctDNA testing. This phase III international trial compares a new drug, elacestrant, with standard endocrine therapies to determine which is better at preventing distant metastasis in these patients. The study includes a ctDNA screening phase to identify eligible patients who have no evidence of distant metastases. During the ctDNA screening phase, patients will undergo blood tests every six months to detect ctDNA while continuing standard endocrine therapy, such as tamoxifen or an aromatase inhibitor. If ctDNA is detected without distant metastases, patients are randomized to receive either elacestrant 400 mg daily or continue their current endocrine treatment. Treatment duration varies from 2 to 6 years depending on prior endocrine therapy exposure, followed by physician-directed care after protocol completion. Participants will have regular follow-up visits with ctDNA tests at weeks 4, 16, and every 16 weeks thereafter for up to three years to monitor disease markers. Imaging studies including mammograms, bone scans, and CT scans will be performed regularly to check for cancer recurrence. Researchers will measure outcomes such as distant metastasis-free survival and quality of life over a long-term period, with safety and survival assessments continuing up to nearly 12 years after study entry.

Researchers are evaluating patient-reported outcomes and real-world data on the use of trastuzumab deruxtecan T-DXd in adults with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer. This observational study focuses on the effectiveness and safety of T-DXd as used in routine clinical practice in Germany, including how patients respond to the treatment over time. The study is non-interventional and involves patients receiving T-DXd according to approved guidelines. The study includes two groups one with patients having HER2-positive tumors and another with patients having HER2-low or HER2-ultralow tumors. All patients receive T-DXd treatment as recommended by the products summary of characteristics, and all medical decisions including treatment schedules are made by the treating physicians. Participants will also be informed about the use of a digital healthcare application DiGA to support their care. Participants will be observed for up to 60 months to track the time until the next treatment or death, whichever occurs first. Patient quality of life will be assessed six months after starting treatment using specific questionnaires FACT-B and FACT-G. Other data collected will include safety and efficacy outcomes reported during regular clinical visits. The study aims to enroll approximately 800 patients, with about 400 in each cohort, and will continue until the end of 2031.

This research aims to evaluate if the experimental combination of sacituzumab govitecan-hziy SG and pembrolizumab given after surgery is effective and safe compared to the treatment of physicians choice TPC in adults with triple negative breast cancer TNBC who still have invasive disease after surgery and pre-surgical treatment. The study focuses on participants whose cancer remains after neoadjuvant therapy and surgery, exploring new options to improve outcomes in this challenging condition. Participants are randomly assigned to one of two treatment groups. One group receives sacituzumab govitecan-hziy intravenously at 10 mgkg on Days 1 and 8 of a 21-day cycle plus pembrolizumab 200 mg intravenously on Day 1 of each cycle, for up to 8 cycles. The other group receives the treatment of physicians choice, which includes pembrolizumab alone or pembrolizumab plus oral capecitabine for 8 cycles. Treatment continues until 8 cycles are completed, disease recurrence, unacceptable side effects, physician decision, withdrawal, or death. During the study, participants undergo regular assessments to measure invasive disease-free survival for up to 60 months as the primary outcome. Secondary outcomes include overall survival up to 96 months, distant disease-free survival, recurrence-free survival, and monitoring of treatment side effects and laboratory abnormalities. Researchers also evaluate quality of life using questionnaires. The total participation includes treatment cycles followed by long-term monitoring to assess effectiveness and safety over several years.