Urraween

Researchers are studying women with a newly diagnosed invasive breast cancer that is node negative and 3 cm or smaller in size to compare two types of radiation therapy after breast-conserving surgery BCS. The study aims to see if partial breast irradiation PBI given once daily over one week is not worse than whole breast irradiation WBI in preventing cancer return and whether it results in better cosmetic outcomes. This is a randomized, single-blind trial focusing on local recurrence and patient-assessed cosmesis three years after treatment. Participants will be randomly assigned to receive either PBI or WBI. Both treatments deliver a total of 26 Gy radiation in 5 fractions, given once daily over 5 to 7 days with up to 8 days allowed for scheduling reasons. PBI targets the tumor bed plus a margin of normal tissue, while WBI targets the whole breast. Patients will not know which treatment they receive to avoid bias in cosmetic assessments. Stratification factors include tumor size, estrogen receptor status, and clinical center. During the study, participants will be monitored for local recurrence annually for five years and will assess their cosmetic outcome at three and five years post-treatment. Researchers will also evaluate survival, disease-free survival, radiation side effects, and quality of life at various intervals. Clinical assessments and nurse evaluations of cosmesis will occur at three and five years. Overall, participant involvement spans several years with multiple follow-up visits to measure outcomes and safety.

Researchers are evaluating the effectiveness and safety of combining calderasib with pembrolizumab as the first treatment for people with locally advanced or metastatic non-small cell lung cancer NSCLC that has a specific KRAS G12C mutation and a PD-L1 tumor proportion score of 50% or higher. The study compares this combination to pembrolizumab with a placebo to see if it improves the time participants live without the cancer worsening and overall survival. Participants receive pembrolizumab through an intravenous infusion every 21 days for up to 35 cycles. They also take calderasib or a matching placebo by mouth daily until they meet criteria to stop treatment. The study is randomized and double-blind, meaning neither participants nor researchers know who receives calderasib or placebo. During the study, participants will have regular assessments to monitor cancer progression, overall survival, response rate, and quality of life measures through questionnaires. Safety will be closely monitored by tracking adverse events and treatment discontinuations. The study may last up to about 56 months, including follow-up to observe long-term outcomes and quality of life changes.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.