Steyr

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 conducting a Phase III, randomized, open-label multicenter study to evaluate the effectiveness and safety of giredestrant compared with fulvestrant. Both drugs are combined with the investigators choice of a CDK46 inhibitor palbociclib, ribociclib, or abemaciclib in participants with estrogen receptor-positive ER, HER2-negative advanced breast cancer who have become resistant to prior adjuvant endocrine therapy. Participants will be randomly assigned to one of two groups one group will receive giredestrant 30 mg orally daily on Days 1-28 of each 28-day cycle, while the other will receive fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and Day 1 of subsequent 28-day cycles. Both groups will also receive a CDK46 inhibitor chosen by the investigator, with dosing schedules depending on the specific inhibitor selected. Preperimenopausal women and men will receive a luteinizing hormone-releasing hormone LHRH agonist during treatment. Participants will be assessed for progression-free survival over up to 5 years, with additional measures including overall survival, response rates, duration of response, clinical benefit, and quality of life. Safety will be monitored through adverse event reporting, vital signs, and laboratory tests during treatment and up to 28 days after the last dose. The study is led by Hoffmann-La Roche and aims to provide detailed information on the treatments effects in this patient population.

Metastatic colorectal cancer mCRC is a serious condition with limited treatment options after multiple therapies. Researchers are gathering detailed information on patients with mCRC who have already had at least two lines of systemic therapy. This registry aims to understand how these patients are treated and how they fare over time, collecting data from multiple cancer centers in Austria to better evaluate treatment patterns and outcomes. The study involves collecting existing medical data from patient charts, including treatment histories, test results, and imaging studies. Tumor tissue samples from deceased patients will be stored in a central biobank, and additional biological samples may be requested for specific research questions. No new diagnostic or treatment procedures are required beyond routine care. Data collection will continue until patient death or loss to follow-up. Participants involvement includes providing consent for their routine medical data to be recorded in the registry. Researchers will monitor overall survival, progression-free survival, response rates, and potential predictive biomarkers over a period of up to 10 years. Patient confidentiality is maintained by assigning unique identifiers, and no extra visits or therapies are needed beyond usual care.

Researchers are collecting data from patients with myeloid diseases, including myelodysplastic syndromes MDS, chronic myelomonocytic leukemia CMML, acute myeloid leukemia AML, and primary myelofibrosis PMF. This observational study gathers real-world information about how these diseases are managed in Austria and potentially other countries in the future. It aims to better understand treatment patterns and outcomes for these conditions. The study uses an electronic case report form where clinical trial staff and physicians enter routine medical data already recorded in patient charts. Optional quality of life assessments, such as EQ-5D-5L and EORTC QLQ-C30 questionnaires, may also be collected with proper approval. There are no experimental treatments involved, as it is a non-interventional registry. Participants provide informed consent and their medical records are reviewed over time to assess treatment types, responses, survival, safety, and quality of life. The study monitors these outcomes until completion, which is expected within about 100 months. This allows researchers to observe long-term patterns and effects of treatments in everyday clinical practice.

Researchers are studying metastatic breast cancer, the most common cancer among women worldwide, with a focus on patients in Austria. This study is the first Austrian-wide registry to systematically collect and document data on metastatic breast cancer cases. The aim is to understand epidemiological trends and treatment patterns, including tumor characteristics and patient outcomes. The study collects both retrospective and prospective data from multiple centers across Austria. It records detailed information on tumor subtypes, initial disease progression, treatment sequences, and patient medical histories. This registry also includes data on male breast cancer patients to assess gender differences in treatment and outcomes. Participants provide anonymized medical information, including tumor characteristics, treatment details, and survival data. Researchers will analyze patterns of metastasis, treatment responses, and survival rates at 1, 2, and 5 years after metastasis diagnosis. The registry aims to offer insights into treatment quality and outcomes over a 10-year period.

Researchers are studying metastatic pancreatic ductal adenocarcinoma PDA in adults who have not been previously treated for this condition. The trial evaluates the effect of adding SBP-101, a small molecule polyamine metabolic inhibitor, to the standard chemotherapy regimen of gemcitabine and nab-paclitaxel. This randomized, double-blind, placebo-controlled, multicenter study aims to assess overall survival and other important outcomes in about 600 patients. Participants will receive either SBP-101 combined with nab-paclitaxel and gemcitabine or a placebo with the same chemotherapy drugs. The treatments are given as injections, and the study includes two groups one experimental arm receiving SBP-101 plus chemotherapy and one control arm receiving placebo plus chemotherapy. The safety and effectiveness of treatments will be monitored throughout the trial by an independent committee. During the study, patients will be followed for overall survival up to 100 weeks or until death. Researchers will also measure progression-free survival, responses seen on scans, and quality of life. Assessments include imaging with CT or MRI, blood tests, and monitoring of side effects. Participants must consent to the study and meet specific health criteria, and safety will be closely observed throughout the trial period.