Deggendorf

Researchers are assessing the effectiveness of avapritinib (BLU-285) in managing indolent systemic mastocytosis (ISM) among patients in Germany. This non-interventional study aims to fill gaps in understanding the natural history and treatment outcomes of ISM, particularly in participants whose symptoms are not adequately controlled with current symptomatic treatments. The study observes participants in real-world clinical settings without altering their standard care. Avapritinib is given as an oral tablet, and treatment decisions are made by healthcare providers as part of routine care for those with moderate to severe ISM symptoms. Participants start avapritinib treatment at the provider's discretion, following approved prescribing guidelines. No other interventions are assigned by the study, emphasizing observation of usual care in a real-world environment. Participants are followed for up to 24 months, during which researchers monitor changes in quality of life related to mastocytosis using the Mastocytosis Control-quality of Life (MC-QoL) Questionnaire, assessed at the start and at 6 months. The study also collects data on symptom control and safety, focusing on participants who have not previously used avapritinib. This long-term observation helps understand treatment effectiveness and patient experiences over time.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are evaluating treatments for patients with generalized Mantle Cell Lymphoma in this Phase 3 trial. The study aims to identify one of three treatment approaches as a future standard by comparing failure-free survival, which measures the time from treatment start until stable disease, disease progression, or death. Secondary goals include assessing overall survival, progression-free survival, response rates, safety, and tolerability of the treatments, as well as exploring factors like minimal residual disease and stem cell mobilization. Participants receive one of three treatment plans: the control arm with alternating R-CHOP and R-DHAP chemotherapy followed by autologous stem cell transplantation (ASCT); an experimental arm adding ibrutinib during induction and maintenance with ASCT; or an experimental arm with ibrutinib during induction and maintenance without ASCT. Chemotherapy includes drugs such as rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, dexamethasone, Ara-C, and cisplatin. Ibrutinib is given in certain induction cycles and as daily maintenance for two years. ASCT conditioning uses specific chemotherapy regimens or total body irradiation depending on the site. During the study, participants undergo regular assessments including imaging, laboratory tests, and evaluations of response and side effects. Researchers monitor failure-free survival up to 10 years, along with secondary outcomes like overall survival, progression-free survival, and safety events. Follow-up includes measuring molecular remission, relapse timing, and quality of life. The total duration includes treatment, maintenance, and long-term observation, with safety and efficacy carefully tracked throughout.

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.

This research aims to understand the experiences of parents who have lost a child during pregnancy or birth. It focuses on gathering insights to develop treatment recommendations for healthcare professionals to better support these parents. The study uses a participatory approach, involving parents who have experienced stillbirth and fetal death as part of the research team. The study follows a multistep mixed-method design. First, workshops and focus groups are held to identify the main needs of affected parents. Then, narrative interviews are conducted to gain a deeper understanding of their experiences before and during the loss. Finally, a Delphi approach is used with parents to translate the findings into treatment recommendations and refine them through consensus. Participants will engage in these activities over the course of the study. Researchers will evaluate parents' experiences during pregnancy and up to seven days after birth. The study collects qualitative data through interviews and group discussions and involves parents in reviewing and confirming the treatment recommendations. This approach aims to ensure that the outcomes are sensitive to parents' needs and experiences.

The trial investigates the effectiveness, safety, and patients' quality of life when using additive chemotherapy after surgery or ablation in patients with metastatic colorectal cancer. This phase III, open-label, randomized, controlled, multicenter study compares two groups: one receiving chemotherapy and the other undergoing active follow-up without additional treatment. All patients have had their metastatic lesions definitively treated before joining the trial. Participants in the chemotherapy group receive up to six months of treatment with either mFOLFOXIRI or mFOLFOX-6, with up to 12 cycles administered every two weeks. The other group undergoes active surveillance without further chemotherapy. The study includes regular tumor biopsies at screening and upon relapse if possible, aiming to study tumor and blood markers. Imaging scans such as CT or MRI of the chest and abdomen are performed every three months during the first two years, then every six months thereafter, with follow-up continuing for up to five years. Throughout the study, patients are monitored every three months with radiologic assessments, blood tests, and quality of life questionnaires. Researchers aim to detect any cancer relapse through imaging and blood markers and evaluate progression-free survival over 24 months. Safety and clinical status are regularly assessed, and structured follow-up is maintained for both groups up to 60 months after randomization.

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.