Ehingen Donau

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 evaluating the safety, effectiveness, and quality of life for combining Abemaciclib with either an Aromatase Inhibitor or Fulvestrant in women with metastatic hormone receptor-positive, HER2-negative breast cancer. This Phase IV trial focuses on both pre- and postmenopausal patients receiving first-line treatment. A digital health app called CANKADO will be used to track side effects and patient-reported outcomes daily, alongside standard documentation. The study also aims to explore biomarkers to better understand treatment responses and resistance. Participants will receive either Abemaciclib combined with an Aromatase Inhibitor Anastrozole, Letrozole, or Exemestane taken orally twice daily plus daily Aromatase Inhibitor tablets every 24 hours in 28-day cycles, or Abemaciclib with Fulvestrant which is given as an injection on specific days within 28-day cycles. The two treatment groups are experimental and non-randomized, with no masking. The trial includes monitoring for side effects and quality of life throughout treatment. During the study, participants will regularly report side effects and global health status using questionnaires at multiple time points up to 24 months, including specialized breast cancer quality of life modules. Researchers will assess progression-free survival up to 48 months, as well as adverse events, hospitalizations, clinical benefit rate, overall survival, and tumor response. The use of the CANKADO app for side effect reporting is strongly recommended but not mandatory. Participants will be followed for safety and outcomes throughout the trial duration.

Researchers are evaluating the effectiveness and safety of a subcutaneous treatment using one cycle of cladribine for patients with hairy cell leukemia who need treatment. This study focuses on patients who are either untreated or have been previously treated only with alpha-interferon. The goal is to determine the rate of complete remission and to assess whether a second cycle of treatment benefits those with a non-optimal response, defined as detectable residual disease or partial remission four months after the initial treatment. Participants receive cladribine at a dose of 0.14 mgkg body weight administered subcutaneously as a bolus injection once daily for five consecutive days. After four months, remission status is evaluated. Patients showing non-optimal response may be considered for a second treatment cycle. This phase 23 trial is designed to optimize therapy for hairy cell leukemia by closely monitoring treatment response and toxicity. During the study, participants undergo evaluations including disease status assessment through bone marrow and blood tests, with a focus on remission rates four months post-treatment. Researchers track complete remission rates and monitor for residual disease. Safety is also monitored by assessing potential toxicities. Participants general health status and other laboratory tests are reviewed to ensure eligibility and ongoing suitability for treatment throughout the study period, which spans several months with follow-up assessments.