Jesus Maria

Researchers are evaluating sacituzumab tirumotecan alone and in combination with pembrolizumab compared to treatment chosen by the physician in participants with hormone receptor positivehuman epidermal growth factor receptor-2 negative HRHER2- breast cancer that is locally advanced, unresectable, or metastatic. The study aims to see if these treatments improve progression-free survival compared to standard physician-chosen therapies. This is a Phase 3 clinical trial assessing advanced breast cancer treatments. Participants are randomly assigned to one of three groups sacituzumab tirumotecan alone given by intravenous infusion every two weeks until disease progression or discontinuation sacituzumab tirumotecan plus pembrolizumab with sacituzumab tirumotecan given every two weeks and pembrolizumab given every six weeks for up to about two years or treatment chosen by the physician, which may include various chemotherapy options such as paclitaxel, nab-paclitaxel, capecitabine, or liposomal doxorubicin, administered with schedules depending on the drug. Treatments continue until disease progression or discontinuation. During the study, participants will have regular assessments including imaging to evaluate progression-free survival, overall survival, response rates, and quality of life measures using questionnaires. Safety is monitored by tracking adverse events and treatment discontinuations. The primary outcome is measured up to approximately 38 months, with additional secondary outcomes followed up to about 77 months. Participants are followed closely through study visits and evaluations throughout the trial period.

Researchers are investigating the effects of vericiguat compared to a placebo in children with heart failure caused by left ventricular systolic dysfunction. This study aims to see if vericiguat is better than a placebo at lowering levels of a heart failure marker called NT-proBNP over 16 weeks. The trial includes a base period and an optional extension period to further evaluate safety and long-term effects. During the base period, participants receive vericiguat orally once daily either as tablets in doses of 2.5 mg, 5 mg, or 10 mg, or as a suspension of 0.2 mgmL or 1 mgmL for up to 52 weeks. Another group receives a placebo in matching forms and schedules. After completing the base period, eligible participants may join the extension period, where they continue to receive vericiguat under similar dosing for additional monitoring. Participants will undergo regular assessments, including measuring NT-proBNP levels at baseline, Week 16, and Week 52 during the base period, as well as monitoring heart events and adverse effects. In the extension period, safety is tracked for up to 8 years, including adverse events and reasons for stopping the study drug. Pharmacokinetics of vericiguat are also studied through blood sampling at scheduled weeks. The total participation time may extend over several years for those in the extension phase.

Researchers are studying advanced breast cancer patients who have mutations in BRCA1, BRCA2, or PALB2 genes and whose cancer is hormone receptor-positive and HER2-negative. The study aims to compare the effectiveness of saruparib AZD5305 combined with camizestrant against standard treatments involving CDK46 inhibitors plus endocrine therapy. This is a phase III clinical trial conducted to evaluate treatment options for this specific breast cancer group. Participants will be randomly assigned to one of four treatment groups saruparib plus camizestrant physicians choice of CDK46 inhibitor plus endocrine therapy physicians choice of CDK46 inhibitor plus camizestrant or saruparib plus physicians choice endocrine therapy. Treatments are given orally or by injection according to the group, and continue until the disease progresses, unacceptable side effects occur, or the participant chooses to stop. During the study, participants will undergo assessments to monitor disease progression and treatment effects, including scans and laboratory tests. Researchers will measure progression-free survival and other outcomes such as overall survival, response rates, and quality of life over several years. Safety and tolerability will also be closely observed throughout the study period, which may last up to about 88 months.