Hameln

Researchers are evaluating the safety, effectiveness, and quality of life for combining Abemaciclib with either an Aromatase Inhibitor or Fulvestrant in women with hormone receptor positive, HER2 negative metastatic breast cancer. This includes both premenopausal and postmenopausal patients receiving first-line treatment. The trial also explores biomarker research to understand responses and resistance to this combined endocrine therapy. Participants receive Abemaciclib 150 mg orally every 12 hours along with either an Aromatase Inhibitor (Anastrozole, Letrozole, or Exemestane) taken once daily in 28-day cycles, or Fulvestrant given by injection on days 1 and 15 of the first cycle, then on day 1 of subsequent 28-day cycles. Side effects and patient-reported outcomes are monitored using the CANKADO digital health app, allowing daily tracking alongside standard clinical documentation. During the study, patients regularly report symptoms and side effects through the app, and undergo laboratory tests, imaging, and clinical assessments to monitor disease progression and treatment safety. The main outcome measured is progression-free survival over up to 48 months. Safety and quality of life are also closely observed throughout the trial period.

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.