Gerlingen

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 effects of stopping CDK4/6 inhibitors in women with metastatic hormone receptor-positive, HER2-negative breast cancer who have had long-lasting disease control. This phase II, low-intervention trial aims to assess whether patients can maintain stable disease after discontinuing CDK4/6 inhibitors following at least 12 months of combined treatment with endocrine therapy. The study focuses on long-term disease stabilization and progression-free survival 12 months after randomization. Participants are assigned to either continue or discontinue CDK4/6 inhibitors such as Palbociclib or Abemaciclib while maintaining endocrine therapy. The study is open-label and multicenter, allowing close observation of treatment effects. During the trial, patients will be monitored to see if disease control persists after stopping the CDK4/6 inhibitor treatment. Throughout the study, participants undergo regular assessments including evaluations of disease status and safety monitoring. Researchers will track progression-free survival at 12 months after randomization as the primary outcome. The trial includes detailed monitoring of participants' health and treatment responses to understand the impact of discontinuing CDK4/6 inhibitors in this patient population.

Researchers are evaluating the patient-reported outcomes, real-world efficacy, and safety of trastuzumab deruxtecan (T-DXd) in patients with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer receiving treatment according to the approved product guidelines in routine clinical practice in Germany. This prospective, non-interventional, multicenter study includes approximately 800 patients divided equally into HER2-positive and HER2-low/ultralow groups. Patients will also be informed about the use of a digital healthcare application (DiGA). Eligible patients must be receiving T-DXd as part of their routine care, with all diagnostic tests and treatment visits determined by their treating physicians and not by the study protocol. The study observes patients treated with T-DXd in line with the applicable summary of product characteristics. Treatment decisions, including visit frequency and procedures, follow standard clinical practice rather than study-mandated schedules. Participants will be followed to monitor the time from the first dose of T-DXd until the start of the next treatment or death, assessed for up to 60 months. Data collection will include patient-reported outcomes, safety information, and real-world clinical data. The study aims to gather comprehensive information on treatment effects and patient experiences during routine care without altering their treatment plan.