Rodewisch

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 best neoadjuvant therapy for patients with less advanced HER2-positive early breast cancer EBC. This Phase 2 trial focuses on improving treatment outcomes by comparing trastuzumab-deruxtecan T-DXd with standard chemotherapy combined with trastuzumab and pertuzumab. The study targets patients with low to intermediate risk HER2 EBC, aiming to show higher rates of complete tumor response and excellent survival outcomes. Participants receive different treatment regimens depending on their risk group and assigned study arm. Treatments include 12 or 18 weeks of T-DXd alone or combined with standard chemotherapy, trastuzumab, and pertuzumab. After neoadjuvant treatment, post-neoadjuvant therapy with T-DXd or standard care continues for up to one year, with adjustments based on tumor response. Some patients may receive additional chemotherapy depending on residual tumor burden. During the study, participants undergo regular evaluations including tumor response assessments and safety monitoring for adverse drug reactions. Key outcomes measured are pathological complete response rate after neoadjuvant therapy and distant disease-free survival after three years. Researchers also track various survival outcomes, quality of life, and treatment-related side effects over time. Participants are followed until study completion in 2030, with detailed monitoring throughout the treatment and follow-up phases.