Grabs

Femara (letrozole) is an extensively investigated, marketed aromatase inhibitor (AI) widely used as treatment in the maintenance phase of estrogen-receptor (ER) positive breast cancer, as it inhibit the synthesis of estrogens. Estrogen is a well known driver of cancer growth in ER-positive tumors and a high percentage of the epithelial ovarian cancers express ER as well. Of which low grade ovarian cancers demonstrates the highest level of expression, supporting our strategy of a sub-group analysis (LOGOS). Therefore, letrozole in this study be investigated prospectively and evaluated as maintenance therapy after standard surgical and chemotherapy treatment in comparison to placebo (which is the current standard maintenance treatment) in subjects with primary, ER-positive low or high grade serous or endometrioid epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) of FIGO Stage II-IV, whose cancer has not progressed by the end of the platinum-based chemotherapy. The objectives are to evaluate the letrozole maintenance treatment compared to placebo in terms of * progression-free survival (PFS; primary endpoint) * overall survival (OS) * quality-adjusted progression free survival (QAPFS) * time to first subsequent treatment (TFST) * quality-adjusted time without symptoms of toxicity (Q-TWiST) * health related quality of life (QoL) assessed by EQ-5D-5L, FACT-ES and FACT-O questionnaires Methods: 540 for this study eligible subjects are 1:1 allocated in this randomized, controlled, double-blinded, multi-centre study to either the test (letrozole) or control (placebo) group. The maximum maintenance treatment duration is 5 years or until symptoms of toxicity or progression of underlying disease. Health and health-related quality of life will continuously be assessed at study entry and during routine recalls which are scheduled every 12 weeks for the first 2 years, followed by every 24 weeks for the next 3 years. Procedures performed to assess the participants' health are the same as are performed during the regular routine ovarian cancer follow-up visits: blood tests, physical as well as gynaecological examinations and may include imaging. In addition, the participants are asked to complete during the study quality of life (QoL) specific questionnaires and wear an activity tracker for one week just before the scheduled visits. These assessments will be used for the evaluation of letrozole's efficacy and burden in comparison to the standard maintenance treatment. Survival follow-up data after the mainentance treatment duration of 5 years (study end) are obtained for up to another 7 years.

Gastroentero-pancreatic neuroendocrine tumors (GEP-NETs) are rare tumors that arise from the neuroendocrine system in the gastrointestinal tract and pancreas. This registry study aims to better understand these tumors by collecting detailed clinical information from patients diagnosed with GEP-NETs in Switzerland. Since limited knowledge exists about the biology and treatment of these tumors, the study focuses on gathering data to improve understanding and management strategies. Patients with a confirmed diagnosis of neuroendocrine tumors from any location who agree to participate will have their information entered prospectively into a secure, anonymized database. Data collection involves visits from study nurses to healthcare centers, where patient files are reviewed and information is recorded. There are no specific treatments assigned by this registry; instead, it tracks various treatment approaches used in Switzerland. Participants contribute data that includes tumor types, treatments received, and outcomes such as mortality and hospitalization rates. The study reviews and evaluates this information regularly to identify patterns and assess patient outcomes over time. The main outcome measured is tumor-related mortality every five years, helping to monitor long-term effects. This registry allows for improved knowledge sharing across hospitals and practitioners in Switzerland to enhance care for patients with neuroendocrine tumors.