Reus

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating vepugratinib, a new medicine, to see if it is safe and helpful for people with advanced or metastatic urothelial carcinoma, a type of bladder cancer with FGFR3 genetic changes. This Phase 3 study compares vepugratinib combined with enfortumab vedotin and pembrolizumab against a placebo combined with these same drugs. The trial is sponsored by Eli Lilly and Company and aims to assess treatment safety and effectiveness over a long period. Participants receive either vepugratinib or a placebo orally, together with enfortumab vedotin and pembrolizumab given by intravenous infusion. The study uses a double-blind, randomized design with parallel groups to compare these treatments. There is a safety lead-in phase followed by the main treatment phase, and study participation may last up to approximately 6 years. During the trial, participants will have regular assessments including monitoring for treatment-related side effects, tumor response, progression-free survival, overall survival, and quality of life using questionnaires. Researchers will collect blood samples to measure drug levels and evaluate health status at baseline and throughout the study. Safety and effectiveness outcomes will be tracked up to 90 months, with continuous monitoring to ensure participant well-being over the long-term study period.

This trial is focused on adults with cancer who are receiving chemotherapy and experience nausea and vomiting as side effects. Researchers are studying a drug called LY3537021 to see how well it controls these symptoms and to evaluate its safety. The study is a Phase 2, double-blind, placebo-controlled trial designed to better understand the treatment options for chemotherapy-induced nausea and vomiting in this population. Participants are randomly assigned to receive either LY3537021 or a placebo, both given as a subcutaneous injection before chemotherapy. All participants also receive standard anti-nausea treatments, which may be taken orally, intravenously, or through skin patches. The chemotherapy drugs involved include cisplatin or an anthracycline and cyclophosphamide combination. The study treatment is given prior to chemotherapy, and the trial lasts about two months per participant. During the study, participants will be monitored for nausea and vomiting from the time of their chemotherapy infusion through up to five days afterward. Researchers will collect data on symptom control, the need for rescue medications, and drug levels in the body. Participants will complete diaries to track nausea severity. Safety and response to treatment are carefully observed. The study aims to measure how many participants have a complete response to nausea and vomiting during the delayed phase after chemotherapy.

Researchers are conducting an observational study to assess patient satisfaction, effectiveness, and safety of subcutaneous Atezolizumab treatment in people with certain types of lung cancer and hepatocellular carcinoma. The study focuses on participants treated for approved indications in routine clinical practice across multiple countries and centers. It collects primary data on patient-reported outcomes and clinical effectiveness in real-world settings. Participants receive Atezolizumab as prescribed by their doctors for conditions including early-stage non-small cell lung cancer NSCLC after surgery and chemotherapy, metastatic NSCLC, extensive-stage small cell lung cancer ES-SCLC, and advanced or unresectable hepatocellular carcinoma HCC. Atezolizumab administration is at the physicians discretion and is independent of study participation. The study includes several cohorts based on cancer type and stage. During the study, participants report treatment satisfaction using the Therapy Administration Satisfaction Questionnaire Subcutaneous TASQ-SC at cycles 2 and 3, each lasting 3 weeks. Researchers also evaluate overall survival up to about 3.5 years, quality of life with the EORTC QLQ-C30 questionnaire, and record adverse events during the same period. The study aims to monitor patient experience, clinical outcomes, and safety over the long term, with participation lasting several years.

Researchers are investigating whether using artificial intelligence AI to guide monitoring and timing of ovulation trigger in women undergoing ovarian stimulation for in vitro fertilization IVF can achieve clinical outcomes similar to traditional physician-led decisions. This trial aims to compare AI-assisted decision-making with routine clinical management to optimize the number of eggs retrieved, improve workflow efficiency, and reduce clinical workload, especially weekend procedures. Participants will be randomly assigned to one of two groups one where trigger decisions are made by the physician assisted by the AI software called STIMAI, and the other where trigger timing is determined by the physician alone based on clinical judgement. The AI software analyzes patient data to predict the optimal trigger day, offering options for triggering today or tomorrow, while the physician makes the final decision. The study focuses on individualized treatment to improve outcomes and scheduling. During the study, participants will undergo controlled ovarian stimulation with regular monitoring including ultrasounds. Researchers will measure the number of mature eggs retrieved about 34-36 hours after ovulation trigger, as well as other outcomes like follicle counts, length of stimulation, and number of clinic visits. The trial also tracks spontaneous ovulation and the distribution of retrieval procedures throughout the week. Participation will last through the stimulation cycle until egg retrieval, with assessments of both clinical results and process efficiency.

Researchers are evaluating two different treatments for breast cancer patients who have a positive sentinel lymph node after receiving neoadjuvant systemic therapy. The study aims to compare axillary radiotherapy ART with axillary lymph node dissection ALND to see which approach results in less risk of lymphedema and how each affects recurrence and overall survival. This trial is a prospective, randomized, open-label, parallel-assigned, multicenter study involving 820 patients over 5 years, including those treated with chemotherapy and hormone therapy. Participants are randomly assigned to one of two groups. One group receives axillary radiotherapy targeting levels I and II plus level III and supraclavicular areas, with or without the internal mammary chain, but without lymphadenectomy. The other group undergoes axillary lymph node dissection along with radiotherapy to level III and supraclavicular areas, with or without the internal mammary chain. The study includes a pilot phase with the first 200 patients and plans interim analysis to assess progress. During the trial, participants will be monitored for disease-free survival, overall survival, and the incidence of lymphedema for up to 5 years, with lymphedema tracked for up to 3 years after surgery. Researchers will evaluate outcomes related to recurrence and quality of life. The study involves regular assessments including imaging to evaluate axillary response and follow-up visits to monitor health and side effects. Participants are followed closely to understand the long-term impact of the treatments.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are studying women who have survived breast cancer to understand how eating one avocado daily might affect biological aging, measured by the length of telomeres. The study focuses on breast cancer survivors aged 40 to 65, exploring whether dietary changes can influence aging markers and other health indicators such as inflammation, oxidative stress, cardiovascular markers, mental health symptoms, quality of life, and diet quality. This is a randomized controlled trial aiming to compare avocado consumption to a habitual diet with low avocado intake. Participants will be randomly assigned to one of two groups an intervention group that will consume one avocado daily for four months alongside their usual diet, and a control group that will continue their usual diet without encouragement to eat avocados. Avocados will be provided free of charge to the intervention group every two weeks, supported by recipe leaflets to help incorporate avocados into their meals. The control group will maintain their regular diet without specific dietary changes. During the study, participants will complete questionnaires, provide blood and urine samples, and undergo measurements like blood pressure and body size assessments at the start and end of the four-month period. Researchers will evaluate changes in telomere length as the primary outcome, alongside secondary measures including telomerase activity, inflammation, oxidative stress, cardiovascular markers, mental health symptoms, quality of life, and diet. The study aims to understand the potential impact of avocado intake on cellular aging and overall health in breast cancer survivors.

Researchers are evaluating zongertinib, an oral drug targeting HER2 mutations, to see if it can improve outcomes compared with standard adjuvant treatments in adults who have had complete surgical removal of Stage II-IIIB non-small cell lung cancer NSCLC with activating HER2 tyrosine kinase domain mutations. This Phase 3, global, randomized, open-label study involves participants who have already received appropriate perioperative systemic therapy, including neoadjuvant or adjuvant platinum-based chemotherapy, with or without immunotherapy. Participants are randomly assigned in equal numbers to receive either zongertinib once daily by mouth for up to 3 years or standard treatment, which may include approved adjuvant immunotherapy or observation depending on local guidelines and patient status. The study compares disease-free survival between these groups and also monitors safety and patient-reported outcomes. Tumor samples are collected centrally to confirm HER2 status. During the study, participants undergo regular assessments to monitor disease status, safety, and quality of life. The primary outcome is disease-free survival, tracked for up to 8 years and 5 months. Secondary outcomes include overall survival and occurrence of significant adverse events over up to 3 years. Participant involvement may last several years, with follow-up continuing after treatment to assess long-term outcomes and safety.