Gerlingen

Researchers are studying the real-world effectiveness, safety, and patient experience 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 patient compliance and quality of life among those treated with ribociclib, abemaciclib with endocrine therapy, or endocrine therapy alone. The goal is to understand treatment decisions and how these therapies perform in routine care settings. Participants receive treatment as prescribed by their doctors based on local guidelines and product information for ribociclib plus aromatase inhibitor with or without LHRH, abemaciclib with endocrine therapy plus or minus LHRH, or endocrine therapy alone plus or minus LHRH. There is no random treatment assignment since this is an observational study. Baseline data are collected shortly before or after treatment initiation depending on the cohort. During the study, patients will be followed for up to 36 months to monitor invasive disease-free survival and other health outcomes. Researchers will collect information on adverse events, treatment modifications, adherence measures, quality of life questionnaires, and socio-economic factors at various timepoints. This will provide insights into treatment tolerability, patient compliance, and overall impact on quality of life in a real-world setting.

Researchers are investigating the effects of stopping CDK46 inhibitors in women with metastatic hormone receptor HR positive, HER2 negative breast cancer who have maintained disease control after long-term treatment. This phase II trial aims to evaluate whether disease stability continues when CDK46 inhibitors are discontinued after at least 12 months of combined treatment with endocrine therapy. The study is open-label, randomized, and conducted at multiple centers. Participants are randomly assigned to one of two groups one group continues both CDK46 inhibitor treatment such as Palbociclib or Abemaciclib and endocrine therapy, while the other group discontinues the CDK46 inhibitor but continues endocrine therapy alone. The study monitors disease progression and treatment effects over time, with a focus on how long patients remain free from disease worsening after stopping the CDK46 inhibitor. During the study, participants will be regularly assessed for disease progression, safety, and quality of life using questionnaires and clinical evaluations. Researchers will measure progression-free survival at 12 months and up to 54 months, time to treatment failure, time to first chemotherapy use, and monitor adverse events. The total participation duration may extend beyond four years, with ongoing evaluations to understand long-term outcomes and safety after stopping the CDK46 inhibitor.

Researchers are evaluating patient-reported outcomes and real-world data on the use of trastuzumab deruxtecan T-DXd in adults with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer. This observational study focuses on the effectiveness and safety of T-DXd as used in routine clinical practice in Germany, including how patients respond to the treatment over time. The study is non-interventional and involves patients receiving T-DXd according to approved guidelines. The study includes two groups one with patients having HER2-positive tumors and another with patients having HER2-low or HER2-ultralow tumors. All patients receive T-DXd treatment as recommended by the products summary of characteristics, and all medical decisions including treatment schedules are made by the treating physicians. Participants will also be informed about the use of a digital healthcare application DiGA to support their care. Participants will be observed for up to 60 months to track the time until the next treatment or death, whichever occurs first. Patient quality of life will be assessed six months after starting treatment using specific questionnaires FACT-B and FACT-G. Other data collected will include safety and efficacy outcomes reported during regular clinical visits. The study aims to enroll approximately 800 patients, with about 400 in each cohort, and will continue until the end of 2031.