Independence

Researchers are evaluating camizestrant, an oral selective estrogen receptor degrader, compared to standard endocrine therapy in patients with early-stage ER-positive, HER2-negative breast cancer. This Phase III open-label study focuses on individuals at intermediate or high risk for disease recurrence who have completed locoregional therapy and at least 2 years, up to 5 years, of standard adjuvant endocrine therapy. The goal is to assess if camizestrant improves invasive breast cancer-free survival and other related outcomes. Participants are randomly assigned to receive either camizestrant or continue with standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors such as exemestane, letrozole, anastrozole, or tamoxifen. Treatment duration for both groups is planned for 60 months (5 years). The study allows prior use of CDK4/6 inhibitors and excludes patients with specific medical conditions or prior use of similar investigational agents. During the study, patients will be regularly monitored for invasive breast cancer-free survival, invasive disease-free survival, distant relapse-free survival, overall survival, and safety measures, including adverse events and changes in laboratory and vital signs. Quality of life assessments related to symptoms like arthralgia, hot flushes, and vaginal dryness will also be conducted. Follow-up for participants will continue for up to 10 years from the last patient's randomization.

This research aims to understand the safety and effects of a study medicine called PF-08653944 in adults who are overweight or obese and have type 2 diabetes. Type 2 diabetes is a condition where there is too much sugar in the blood, and being overweight means carrying excess body weight. The study is a phase 3, randomized, placebo-controlled trial sponsored by Pfizer to evaluate this medicine's impact on weight loss and diabetes management. Participants will receive the study medicine or a placebo via a shot under the skin in the belly area once every week. About 660 out of 1000 participants will get the study medicine while about 330 out of 1000 will receive a placebo, which looks like the medicine but contains no active drug. The study will last about 21 months and involve approximately 14 in-person visits and 5 phone visits. During the study, participants will be trained to self-inject the medicine at home. Researchers will monitor changes in body weight, blood sugar control (HbA1c), waist size, blood pressure, cholesterol levels, and quality of life through various tests and questionnaires at baseline and weeks 64 and 84. Safety will be tracked by recording any side effects or lab abnormalities. The main outcome is the percentage change in body weight from the start of the study to week 64.

Researchers are investigating autonomic dysfunction (AD) and orthostatic intolerance (OI) in patients who have undergone bariatric surgery (BS). This observational study aims to assess how common AD is after BS and to better understand the underlying causes and outcomes. Previous research has shown limited and low-quality evidence on this topic, prompting this study to improve knowledge about AD/OI following bariatric procedures. The study includes both retrospective and prospective phases. Patients who have had BS within the last 3 years or will undergo BS soon are observed to characterize the development of AD/OI after surgery. Bariatric surgeries studied include gastric bypass, sleeve gastrectomy, and biliopancreatic diversion with duodenal switch. The study does not involve any experimental treatments but focuses on monitoring and collecting data about AD/OI symptoms and progression. Participants will provide consent and maintain follow-up with their bariatric surgery team. Researchers will evaluate the prevalence and outcomes of autonomic dysfunction at around 3 months after surgery. Data collection includes medical history, symptom tracking, and follow-up evaluations to better define AD/OI characteristics. The study will end in December 2025, allowing for thorough observation and outcome assessment over time.

Researchers are evaluating the efficacy and safety of once-weekly injectable MET097 in adults who are overweight or have obesity along with weight-related health problems, excluding type 2 diabetes. This Phase 3 clinical trial, sponsored by Pfizer, aims to assess how MET097 affects body weight and other health measures over a long period of time. The study will last 84 weeks, with the primary results measured at 64 weeks and additional findings at 84 weeks. Participants will be randomly assigned to receive one of three different doses of MET097 or a placebo. All treatments are given as once-weekly injections under the skin. The study is double-blinded, meaning neither participants nor researchers know who receives MET097 or placebo during the trial. The trial includes multiple groups to compare the effects of different doses of MET097 against placebo. Throughout the study, participants will have regular assessments to monitor changes in body weight, blood pressure, cholesterol levels, blood sugar markers, and quality of life measures. Researchers will also track safety by recording any side effects or adverse events. The study involves careful monitoring of laboratory tests and questionnaires to evaluate physical function and eating behaviors. Participant involvement spans the full 84 weeks, including both treatment and follow-up evaluations.

Researchers are evaluating the study medicine called elranatamab in people with multiple myeloma (MM) that has returned or not responded to previous treatments, including prior anti-CD38 antibody and lenalidomide therapies. This Phase 3 trial aims to compare elranatamab with other commonly used combination therapies to understand its safety and how well it works for people with relapsed or refractory MM. Participants will be randomly assigned to receive either elranatamab alone or an investigator's choice of combination therapies. Elranatamab is given as a weekly shot under the skin at the study clinic, which may become less frequent later. The combination therapies include various medicines taken by mouth and given as shots or intravenous infusions at the clinic. Treatment continues until the MM no longer responds. During the study, participants will visit the clinic regularly for monitoring and assessments, including evaluations of disease progression and response to treatment. Follow-up contacts by telephone or visits will continue after treatment ends. The main measure is progression-free survival, and other outcomes include overall survival, response rates, quality of life, and safety. The study may last up to about five years for some measures.

Researchers are evaluating whether observation alone is as effective as continuing treatment with pembrolizumab in preventing cancer recurrence in patients with early-stage triple-negative breast cancer (TNBC) who achieved a complete response after receiving chemotherapy combined with pembrolizumab before surgery. This phase III trial aims to compare these approaches in terms of recurrence-free survival, quality of life, and overall value of care. The study also examines side effects, survival rates, and financial impacts associated with the treatments. Participants are randomly assigned to one of two groups after completing neoadjuvant chemotherapy with pembrolizumab and surgery. One group continues pembrolizumab treatment intravenously every 3 or 6 weeks for 27 weeks, while the other group undergoes observation without additional treatment during this period. Both groups will have tumor biopsies and blood samples collected, along with imaging tests like mammography, breast ultrasound, or MRI during follow-up. Throughout the study, participants will be monitored for cancer recurrence, survival, adverse events, and quality of life using questionnaires and assessments. Blood and tumor samples will help track biological markers. The primary outcome is recurrence-free survival over up to 10 years. Secondary outcomes include adverse event rates, overall survival, and local recurrence. Additional evaluations cover financial costs, work productivity, and patient-reported side effects. The total participation may involve long-term follow-up and several assessments over approximately 27 weeks and beyond.

This observational study focuses on patients with Premature Ventricular Contractions (PVCs), either with symptoms or without, to better understand the occurrence of all types of cardiac arrhythmias detected through long-term monitoring. Researchers aim to assess the role of implantable loop recorders (ILRs) in managing PVCs and to investigate clinical, biomarker, and radiological signs of myocarditis in this group. The study is conducted at a single center and will follow about 50 patients over 12 months. Participants will be monitored using implantable loop recorders from the time they first present with PVCs or ventricular arrhythmias. These devices will continuously record heart rhythms to detect arrhythmias. Alongside this, patients will be evaluated for evidence of myocarditis through clinical assessments and biomarker and imaging tests. The study does not involve experimental treatments but focuses on monitoring and data collection. During the 12-month follow-up, patients will undergo evaluations to identify unrecognized myocarditis, monitor PVC burden, assess improvements in heart function such as left ventricular ejection fraction, and detect associated atrial and ventricular arrhythmias. The study includes regular assessments and data collection to understand the link between myocarditis and arrhythmias. Participants will be closely observed to gather information that may inform future management of PVCs using ILRs.

Researchers are evaluating patients with metastatic HER-2-positive breast cancer who are receiving trastuzumab-based therapy and are at risk of heart problems. The study includes two groups: one large observational group taking beta blockers, ACE inhibitors, or ARBs alongside trastuzumab, and a smaller randomized group comparing the effects of carvedilol versus no treatment. The aim is to understand the occurrence of heart issues and whether carvedilol might help prevent cardiac side effects from chemotherapy. Participants are assigned to one of three arms based on their current medications. Patients not on beta blockers, ARBs, or ACE inhibitors are randomized to either receive carvedilol orally twice daily or no study intervention. Those already taking these heart medications enter an observational arm without additional treatment. Treatment and observation continue for up to 108 weeks unless disease progression or unacceptable side effects occur. Throughout the study, participants undergo heart function monitoring with echocardiograms every 12 weeks and provide blood samples for biomarker analysis. Researchers track the time to the first sign of heart dysfunction and any cardiac events, as well as adherence to medication and side effects. The study also collects data to develop models predicting heart risk and banks samples for future research. Participant involvement may last over two years with regular assessments to monitor safety and heart health.

Researchers are evaluating how well serum tumor marker directed disease monitoring (STMDDM) works compared to usual care in patients with hormone receptor positive, HER2-negative metastatic breast cancer. This trial aims to see if monitoring with serum tumor markers can provide similar overall survival outcomes to the standard approach, which involves regular imaging scans. The study also looks at healthcare costs, patient anxiety, and quality of life related to these monitoring methods. Participants are randomly assigned to one of two groups. In the usual care group, patients receive imaging studies at least every 12 weeks and may have serum tumor marker tests as determined by their doctor. In the STMDDM group, patients have blood tests for specific tumor markers every 4 to 8 weeks, and imaging scans are only done if these markers indicate a possible progression of disease. Both groups continue their monitoring for up to 312 weeks unless the disease progresses. During the study, participants undergo regular assessments including blood tests for tumor markers, imaging scans as needed, and questionnaires about anxiety and quality of life. Researchers track overall survival for up to 312 weeks and compare healthcare costs and patient-reported outcomes for up to 48 to 102 weeks. The study also collects data on how often and by what methods disease monitoring is performed, along with patient and physician preferences related to monitoring.

Researchers are evaluating an investigational drug called VYD2311, a monoclonal antibody designed to reduce the risk of getting COVID-19. This study includes adults and adolescents aged 12 years and older. Participants will receive either VYD2311 or a placebo to assess how well VYD2311 prevents COVID-19 infection. The study also examines the safety, how the drug is processed by the body, immune responses, and the drug's ability to block the virus. Participants will receive three monthly injections as part of one of three groups: a single dose of VYD2311 followed by placebo injections, multiple doses of VYD2311, or placebo injections only. The injections are given into the muscle of the upper thigh or upper arm on Day 1, Day 30, and Day 60. During the 90 days following the first injection, participants will have blood drawn at specific times to measure drug levels, immune reactions, and virus neutralization. Researchers will monitor for COVID-19 symptoms confirmed by testing, safety through reports of side effects, and overall drug tolerability. The total study participation lasts approximately 90 days after the first dose.