Ban Phaeo

Researchers are evaluating how well elritercept works compared to epoetin alfa in treating anemia in adults with very low, low, or intermediate risk myelodysplastic syndromes (MDS) who need regular red blood cell (RBC) transfusions. The study aims to see if elritercept can reduce the need for RBC transfusions, improve tiredness without transfusions, lower transfusion burden, and enhance quality of life. It also examines the immune response to elritercept and monitors its safety. Participants receive either elritercept or epoetin alfa as subcutaneous injections. The study is a phase 3, multicenter, randomized trial comparing the efficacy and safety of these two drugs. The treatment period lasts through 24 weeks, with each cycle lasting 28 days. Researchers monitor participants for RBC transfusion independence lasting at least 12 weeks and a significant increase in hemoglobin levels. During the study, participants undergo regular assessments including blood tests to measure hemoglobin and other blood counts. Researchers track transfusion needs and quality of life reports. Safety is carefully monitored throughout the trial. Participants are involved from screening through 24 weeks of treatment, with evaluations to measure the effectiveness of the treatments and any side effects.

Researchers are evaluating the effectiveness and safety of palazestrant combined with ribociclib compared to letrozole combined with ribociclib in adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. This phase 3, international, multicenter, randomized, double-blind, active-controlled trial involves participants who have not received prior systemic anti-cancer treatment for their advanced disease. The study aims to enroll approximately 1,000 men and women with locally advanced or metastatic breast cancer. Participants will be randomly assigned to one of two treatment groups. One group will receive palazestrant 90 mg once daily plus ribociclib 600 mg once daily on days 1 to 21 of each 28-day cycle, along with a letrozole-matching placebo once daily. The other group will receive letrozole 2.5 mg once daily plus ribociclib 600 mg once daily on days 1 to 21 of each 28-day cycle, along with a palazestrant-matching placebo once daily. Female participants may be pre-, peri-, or postmenopausal, and male and pre/peri-menopausal female participants must agree to take a GnRH or LHRH agonist. During the study, researchers will monitor participants for progression-free survival, measuring the time from randomization until disease progression or death, up to 3.5 years. Assessments will include evaluations of disease status using RECIST 1.1 criteria or bone-only disease assessment, safety monitoring, and laboratory tests to check blood, liver, and kidney function. Performance status and adverse events will also be closely followed throughout the trial to evaluate the treatments' safety and efficacy.