Goslar

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 effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.

Researchers are investigating the real-world use, effectiveness, quality of life impact, safety, and tolerability of the combination of encorafenib and binimetinib in patients with unresectable advanced or metastatic melanoma that has a specific BRAF V600 mutation. This prospective, longitudinal, non-interventional study focuses on patients in Germany, Austria, and Switzerland who receive these drugs after they became commercially available. The study includes patients receiving first or second line treatment, particularly after prior checkpoint inhibitor therapy. The study observes patients treated with encorafenib plus binimetinib according to approved prescribing guidelines (Summary of Product Characteristics). Patients may have started treatment within six months before joining the study or plan to start soon. No experimental interventions are given; instead, the study collects real-life treatment data under routine clinical care in multiple centers across the three countries. Participants will be followed to gather information on progression-free survival at 12 months after starting treatment. Data collected include safety, tolerability, quality of life, and treatment patterns. The study documents patient outcomes and treatment experiences in a naturalistic setting without altering standard care. Participation duration depends on treatment and follow-up schedules determined by routine clinical practice and study timelines.

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 investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

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 evaluating real-world clinical data in women with primary advanced (FIGO stage III or IV) or recurrent endometrial cancer who are receiving first-line treatment with Carboplatin, Paclitaxel, and Durvalumab (CPD). The study focuses on patients treated with CPD followed by maintenance therapy using either durvalumab alone or durvalumab combined with olaparib. This multi-center, prospective, non-interventional study aims to understand the effectiveness, safety, and patient-reported outcomes of these treatments in routine clinical practice in Germany. Participants receive first-line CPD chemotherapy after surgery and/or radiation if applicable. Following this, maintenance therapy is given with durvalumab for patients with DNA mismatch repair deficient tumors (dMMR cohort) or with durvalumab plus olaparib for those with DNA mismatch repair proficient tumors (pMMR cohort). Treatment decisions are made jointly by patients and their physicians as part of standard care, independent of the study itself. During the study, data on treatment effectiveness and safety will be collected along with patient-reported outcomes after the chemotherapy phase. Researchers will monitor real-world time to the next treatment over 12 months. Patients will complete questionnaires and their tumor mismatch repair status must be known. The study includes women aged 18 years or older and involves regular follow-ups to gather comprehensive information about the treatment effects and patient experience.

Researchers are collecting real-world data on patients in Germany with non-squamous metastatic non-small cell lung cancer (NSQ mNSCLC), including large cell neuroendocrine carcinoma if considered similar to NSCLC. The study focuses on patients starting first-line treatment with tremelimumab and durvalumab combined with platinum-based chemotherapy (TDC) following approved guidelines. This research aims to understand how genetic mutations such as KRAS, STK11, KEAP1, and TP53, as well as protein expressions like TTF-1 and PD-L1, affect treatment outcomes in routine clinical practice. The study observes patients who are scheduled to begin treatment with TDC without altering their care, as it is a non-interventional study. Data is gathered prospectively from multiple centers to analyze the effectiveness of TDC, especially in patient subgroups with certain high-risk genetic alterations. No experimental treatments are administered as part of the study. Participants will be monitored over time to measure overall survival up to two years after treatment initiation. Researchers will collect information on patient genetics, tumor markers, treatment responses, and survival outcomes. The study also ensures safety by following approved treatment guidelines and requires informed consent. The aim is to gather detailed data to support better biomarker-guided treatment decisions for NSQ mNSCLC.

Researchers are evaluating two medications, prednisolone and colchicine, for treating acute gout attacks, a common rheumatic disease where urate crystals cause severe joint pain. This study focuses on patients treated in general practice, including those with common health conditions often excluded in past research. The goal is to determine if prednisolone is comparable or only slightly less effective than colchicine in reducing pain during gout attacks. This phase 4 trial is conducted as a double-blind, randomized, controlled study across multiple university sites in Germany. Participants will be randomly assigned to receive either prednisolone or colchicine tablets for five days, with both groups also receiving placebo tablets to maintain blinding. The study uses the double-dummy method to ensure neither patients nor doctors know which treatment is given. Additionally, participants have the option to undergo a dual-energy CT scan of their feet to detect urate crystal deposits, which may provide insights into disease burden. During the study, patients will visit their general practitioner twice: once at the start and again after about one week. They will complete daily diaries tracking pain, joint swelling, tenderness, and any additional pain medication use for six days. Blood tests will check uric acid levels, inflammation, and kidney function. After four weeks, participants will be contacted by phone to assess recovery, recurrence, treatment, work incapacity, and side effects. The main measurement is the highest pain level reported on day 3 after starting treatment.

Researchers are studying the use of venetoclax in people with chronic lymphocytic leukemia (CLL) to understand how effective it is and to assess the costs and patient-reported outcomes when used in real-life medical settings. The study looks at venetoclax given alone or combined with rituximab, obinutuzumab, ibrutinib, or acalabrutinib, based on doctors' decisions and local treatment guidelines. Participants receive venetoclax therapy as prescribed by their physician, which may include the drug alone or along with one of the mentioned combination treatments. The study follows patients in Austria, Germany, and Switzerland, observing how the treatments are used in everyday practice without altering the prescribed therapy. During the study, participants are monitored for up to 12 months to measure the percentage who achieve the best overall response rate (ORR) to treatment. Researchers also collect data on health economics and patient experiences to better understand the impact of these therapies in routine care.