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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 timing of radiotherapy for women with high-risk breast cancer who have already received neoadjuvant chemotherapy (NACT). This phase III international trial compares whether giving radiotherapy before surgery (preoperative) leads to better disease-free survival (DFS) and fewer late radiation side effects compared to the standard approach of radiotherapy after surgery (postoperative). The study aims to find the best timing for radiotherapy to prevent cancer recurrence and improve survival outcomes. Participants will receive either preoperative radiotherapy or postoperative radiotherapy after completing neoadjuvant chemotherapy and surgery. Radiotherapy may target the whole breast or chest wall and, if lymph nodes are involved, the regional lymph nodes as well. The treatment approach follows established guidelines and includes the possibility of an additional radiation boost to the tumor bed in breast-conserving therapy. During the study, participants will be monitored for disease-free survival over 6 to 10 years. Researchers will assess cancer recurrence, survival, and radiation-related late effects. Patients will undergo regular evaluations including clinical assessments and imaging as needed to follow their health status. The trial requires informed consent and includes safety monitoring throughout the long-term follow-up period.

Researchers are studying both early and advanced/metastatic breast cancer to improve therapy decisions and healthcare quality. Metastatic breast cancer patients often have the poorest prognosis, and there is a need to better understand tumor characteristics to guide targeted therapies. This study aims to establish methods for analyzing molecular features of tumors and metastases using blood samples, as tumor biopsies can be invasive and are not routinely performed despite recommendations. Participants will have blood samples taken during routine blood draws to analyze tumor expression, mutations, gene copy number changes, and other molecular markers. The study focuses on creating a comprehensive infrastructure for molecular assessment in breast cancer patients at different stages. The research also explores healthcare outcomes and economics to enhance patient integration and awareness. Participants will be monitored to discover biomarkers that predict progression-free survival in metastatic breast cancer and assess disease-free survival in early breast cancer over up to 60 months. The study involves routine clinical assessments and blood collections, with data collected on tumor characteristics and patient health outcomes. Overall participation spans long-term follow-up to evaluate progression and survival measures.