Radebeul

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 AcoArt drug-coated percutaneous transluminal angioplasty (PTA) balloon catheters in patients with symptomatic arterial disease affecting the lower limbs. This study includes patients with peripheral artery disease across a range of severity, classified by Rutherford Clinical Categories from 2 to 6, including both claudicants and those with critical limb ischemia. The study is a prospective, multi-center, single-arm post-market clinical follow-up to collect real-world data on these devices. Participants will be treated with one of three AcoArt drug-coated balloon catheters (Orchid, Tulip, or Litos), designed to open narrowed or blocked arteries in the iliac, superficial femoral, popliteal, or infra-popliteal regions. Treatments are performed according to current instructions for use and institutional standard practices. The study follows patients after treatment to continue monitoring the performance and safety of these devices in lower limb revascularization. During the study, patients will undergo protocol-specified examinations and follow-up visits to assess outcomes. Researchers will evaluate primary efficacy and safety endpoints at different time points depending on the severity group, including 30 days, 6 months, and 12 months after treatment. Data collected will include clinical assessments, monitoring for adverse events, and treatment success in improving blood flow and symptoms related to peripheral artery disease.