Steyr

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.

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

Colorectal cancer (CRC) is a leading cause of cancer-related deaths in the United States and Europe. Most patients with metastatic colorectal cancer (mCRC) receive palliative care with a median overall survival of 9 to 38 months, depending on various factors. Promising treatment results have been seen in advanced stages, especially in patients receiving third-line therapy and beyond. This research aims to create a disease-specific registry to study treatment patterns and outcomes for mCRC patients who have undergone at least two prior systemic therapies. The registry collects retrospective and prospective data from multiple oncology centers in Austria. It includes patient medical records, testing, and treatment information, along with follow-up data on survival and tumor progression. Imaging studies at three or more lines of therapy are stored centrally in an "imaging-bank," and tumor tissue samples from deceased patients are preserved in a "bio-bank." Additional biomaterial, such as ctDNA or DNA from genotyping, may also be requested for specific research questions. No additional diagnostic or therapeutic interventions are required beyond routine care, and patient confidentiality is maintained through unique identifiers. Participants provide written consent before their data is included, except for deceased patients where no consent is needed. The registry does not interfere with usual treatment routines and only uses existing data from medical charts. Researchers will assess outcomes including overall survival, progression-free survival, response rates, and biomarker identification over a 10-year period. Data collection continues until patient death or loss to follow-up, with contributions from all willing sites.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are collecting data on patients with myeloid diseases, including myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML). This study, called the Austrian Myeloid Registry (aMYELOIDr), is a non-interventional, multi-center database gathering real-world information from various clinical sites in Austria, with potential expansion to other countries in the future. The goal is to understand treatment patterns and patient management in these diseases. The study involves documenting routine clinical data already recorded in patients' medical records using an electronic case report form (eCRF). Additional optional assessments, such as quality of life questionnaires like EQ-5D and QLQ-C30, have been approved but are not required. No experimental treatments are given as part of this registry. Participants will have their clinical information collected and entered by physicians or clinical trial staff throughout the study period, which is expected to last a median of up to 100 months. Researchers will analyze these data to evaluate how patients with myeloid diseases are treated and managed in real-world settings. The study relies on signed informed consent and routine clinical follow-up without additional interventions.

Breast cancer is the most common cancer among women worldwide, with over 5,000 new cases diagnosed annually in Austria. At diagnosis, 5% to 10% of these patients already have distant metastases, and metastasis can develop later in many others depending on lymph node involvement. This study is the first Austrian-wide medical registry to systematically document metastatic breast cancer, aiming to answer epidemiological and treatment-related questions by collecting detailed patient and tumor data. The registry collects both prospective and retrospective data from multiple centers across Austria. It records all tumor characteristics, medical histories, and treatment sequences in anonymized form. The study assesses initial disease progression, tumor characteristics, treatment strategies, and survival outcomes over time. It also evaluates the distribution and characteristics of metastatic breast cancer in male patients and analyzes survival rates at 1, 2, and 5 years after metastasis diagnosis. Participants provide data on histological and radiological evidence of metastases, tumor subtype, treatment history, and disease progression. Researchers monitor overall survival and the frequency of prognostic factors for metastatic breast cancer over a 10-year period. The registry also tracks the influence of gender on treatment approaches and the response to therapies in real-life settings. This comprehensive documentation supports understanding of metastatic breast cancer in Austria and informs future treatment strategies.

Researchers are evaluating the effect of adding SBP-101 to the standard treatment of gemcitabine and nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma who have not received prior treatment for metastatic disease. This randomized, double-blind, placebo-controlled, multicenter study aims to assess overall survival as the primary endpoint, with secondary goals including progression-free survival, radiologic response, and quality of life. The study includes approximately 600 participants and is conducted in phase 2 and phase 3 stages. Participants will be randomly assigned to receive either SBP-101 with gemcitabine and nab-paclitaxel or a placebo with gemcitabine and nab-paclitaxel. SBP-101 is given as a subcutaneous injection and is studied in combination with the chemotherapy drugs nab-paclitaxel and gemcitabine. The study also incorporates a Data Safety Monitoring Board to oversee safety, efficacy, and a planned analysis to determine if the study should continue. During the study, participants will undergo assessments including imaging scans to measure tumor response, quality of life evaluations, and safety monitoring. Overall survival will be tracked from the first dose for up to 100 weeks or until death. The study ensures participants meet specific health and laboratory criteria before enrollment and requires ongoing monitoring to evaluate treatment effects and safety throughout the trial.