Ban Phaeo

Researchers are evaluating the effectiveness and safety of palazestrant combined with ribociclib compared to letrozole combined with ribociclib in adults with advanced breast cancer that is estrogen receptor positive ER and human epidermal growth factor receptor 2 negative HER2-. This phase 3 clinical trial includes women and men who have not yet received systemic treatment for their advanced breast cancer, aiming to find improved first-line treatment options. Participants are randomly assigned to one of two groups one group receives palazestrant 90 mg daily with ribociclib 600 mg daily taken on days 1-21 of each 28-day cycle plus a placebo matching letrozole the other group receives letrozole 2.5 mg daily with ribociclib 600 mg daily plus a placebo matching palazestrant. Treatments are given in repeating 28-day cycles. The study is double-blind and active-controlled, meaning neither participants nor researchers know who receives which treatment, and both groups receive active drugs. During the trial, participants will be monitored regularly for disease progression and survival over approximately 3.5 to 5.5 years. Assessments include tumor response evaluations, safety and tolerability checks, pharmacokinetic blood tests every 28 days, and patient-reported health outcomes. The primary outcome is progression-free survival, measuring the time from randomization until disease worsens or death. Safety monitoring continues for up to 42 days after treatment ends, with the study lasting until 2032.

This research aims to find the best way to start patients with kidney failure on peritoneal dialysis PD, a life-saving treatment done at home. The trial compares the usual full dose PD, prescribed 24 hours a day, 7 days a week, to a lower dose that increases over time, called incremental PD. The study is designed to see if starting with lower doses can maintain quality of life, reduce treatment burden, and be safer and more cost-effective. Participants are randomly assigned to either the incremental PD group, which uses a goal-directed prescription with fewer exchanges per week until an increase is needed, or the full dose PD group, which uses continuous treatment every day. The trial is international, multicenter, and open-label, involving many experts and consumers with PD experience to guide the design. During the study, participants quality of life, kidney function, and safety outcomes such as serious adverse events and hospitalizations will be monitored for up to 18 months. The main focus is on quality of life measured over the first 6 months of treatment. Researchers will track various health events and dialysis complications to assess the impact of the PD dosing strategies. The study may lead to more personalized and less burdensome dialysis treatments worldwide.