Hameln

Researchers are evaluating the safety, effectiveness, and quality of life for combining Abemaciclib with either an Aromatase Inhibitor or Fulvestrant in women with metastatic hormone receptor-positive, HER2-negative breast cancer. This Phase IV trial focuses on both pre- and postmenopausal patients receiving first-line treatment. A digital health app called CANKADO will be used to track side effects and patient-reported outcomes daily, alongside standard documentation. The study also aims to explore biomarkers to better understand treatment responses and resistance. Participants will receive either Abemaciclib combined with an Aromatase Inhibitor Anastrozole, Letrozole, or Exemestane taken orally twice daily plus daily Aromatase Inhibitor tablets every 24 hours in 28-day cycles, or Abemaciclib with Fulvestrant which is given as an injection on specific days within 28-day cycles. The two treatment groups are experimental and non-randomized, with no masking. The trial includes monitoring for side effects and quality of life throughout treatment. During the study, participants will regularly report side effects and global health status using questionnaires at multiple time points up to 24 months, including specialized breast cancer quality of life modules. Researchers will assess progression-free survival up to 48 months, as well as adverse events, hospitalizations, clinical benefit rate, overall survival, and tumor response. The use of the CANKADO app for side effect reporting is strongly recommended but not mandatory. Participants will be followed for safety and outcomes throughout the trial duration.

Researchers are investigating the best timing for radiotherapy in women with high-risk breast cancer who have received neoadjuvant chemotherapy. The study compares preoperative radiotherapy to the standard postoperative radiotherapy to see if it improves disease-free survival and reduces radiation-related late side effects. This is a randomized phase III trial conducted internationally to address an important gap in breast cancer treatment. Participants are randomly assigned to receive either radiotherapy before surgery or the usual radiotherapy after surgery. Both treatments include radiation to the whole breast or chest wall, with additional boosts to the tumor bed when breast-conserving surgery is performed. If lymph nodes are involved, radiation to regional lymph nodes is also given. Treatments follow national and international guidelines and are carefully monitored. Throughout the study, participants will be followed for 6 to 10 years to assess disease-free survival as the main outcome. Researchers will also track local and regional recurrences, metastasis-free survival, overall and disease-specific survival, cosmetic results, quality of life, arm lymphedema, brachial plexus toxicity, and other treatment-related side effects. Regular evaluations by physicians and patient questionnaires will help monitor safety and effectiveness over the long term.