Reston

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 the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

Researchers are evaluating the safety and effects of the study medicine PF-07248144 combined with fulvestrant for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This study focuses on participants whose breast cancer has worsened after prior treatment with CDK46 inhibitor-based therapy. The trial compares PF-07248144 plus fulvestrant to the current standard treatment involving everolimus and endocrine therapy. Participants will be randomly assigned to one of two groups. One group will take PF-07248144 tablets daily at home in 28-day cycles along with fulvestrant injections administered at the clinic. The other group will receive everolimus tablets daily plus either exemestane tablets or fulvestrant injections, based on the study doctors choice. Treatments will continue according to the schedule for each participant. During the study, participants will undergo regular evaluations including scans to measure tumor response, lab tests, electrocardiograms, and monitoring of side effects. Researchers will track progression-free survival up to about two years, as well as overall survival and response duration up to about five years. Safety and drug levels will also be monitored throughout and after treatment. The total duration of participation may span several years depending on individual outcomes.

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 evaluating the use of ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy as the first treatment for people with metastatic non-small cell lung cancer NSCLC. This Phase 3, randomized, double-blind, multiregional study involves around 1600 patients divided into two groups based on NSCLC histology squamous and non-squamous. The main goals are to assess overall survival and progression-free survival, with additional focus on treatment response and safety. Participants are randomly assigned to receive either ivonescimab or pembrolizumab along with platinum-doublet chemotherapy. Both treatments are given as intravenous injections. The two histology groups will be analyzed separately to understand how each treatment works within these subtypes of NSCLC. This design helps compare the effects of the two treatment combinations. During the study, participants will be monitored for survival and disease progression over several years. Safety assessments include tracking side effects from the start of treatment through 30 to 90 days after the last dose or start of other cancer therapies, with follow-up lasting up to two years. The study includes regular evaluations to measure tumor response and overall health, ensuring comprehensive monitoring throughout the participation period.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

This observational study collects mammography data from women to help radiology practices compare their performance with national and regional benchmarks. It focuses on breast cancer screening and diagnosis by using data that facilities are already required to gather under federal rules. The American College of Radiology leads this effort to improve breast imaging quality through shared information. Participants include all women undergoing mammograms, with no specific treatments or interventions applied. The study provides semi-annual feedback reports to Breast Imaging Center of Excellence facilities, showing important benchmarks like cancer detection rates, positive predictive values, and recall rates. Participation is free for these qualified centers. Women in the study have their mammogram data collected and analyzed regularly. The main outcome measured is the cancer detection rate over one year. This monitoring helps facilities understand and improve their screening quality. The study began in 2009 and continues through 2026, with ongoing data collection and reporting throughout this period.

Researchers are comparing treatments for people with active rheumatoid arthritis RA who have not responded well to tumor necrosis factor inhibitor TNFi biologics. This study evaluates switching to either a non-TNFi biologic drug including rituximab, abatacept, tocilizumab, or sarilumab or a targeted synthetic DMARD tsDMARD such as tofacitinib, baricitinib, or upadacitinib. The study aims to provide important real-world data on patient-reported outcomes PROs to help guide treatment decisions, as current guidelines are based on limited evidence and often influenced by insurance or physician preference. Participants will be randomized to one of two groups switching to a targeted synthetic DMARD or switching to a non-TNFi biologic drug. Both treatment options are widely used in clinical practice, but have not been directly compared in a pragmatic trial focusing on PROs. The study will allow patients to continue stable doses of conventional synthetic DMARDs like methotrexate if used for at least three months. The trial will assess changes over 12 months, focusing on functional limitation and quality of life. During the trial, participants will be monitored regularly to assess their function and symptoms using patient-reported tools such as the Health Assessment Questionnaire HAQ. Researchers will collect information on treatment effectiveness, side effects, and safety in a real-world population, including those with other health conditions. The study is designed to reflect routine clinical care and will last for at least 12 months, with follow-up to evaluate changes from baseline in physical function and other outcomes important to patients.

The trial investigates the best timing for vitrectomy surgery to remove symptomatic epiretinal membranes ERM, a common eye condition that can cause visual distortion. It aims to compare outcomes of immediate surgery versus deferred surgery when vision declines, and to identify predictors of visual outcomes and disease progression. The study also evaluates objective measures of metamorphopsia visual distortion and reading speed that have not been previously used in a randomized clinical trial for ERM. Participants are randomly assigned to one of two groups immediate vitrectomy surgery performed within one month of randomization, or deferred surgery where vitrectomy is delayed until certain vision decline criteria or symptoms worsen. Deferred surgery may be triggered by specific decreases in visual acuity or participant request. The study follows participants for 36 months to assess changes in visual acuity and other vision-related measures. Throughout the study, participants undergo regular eye examinations including visual acuity assessments and imaging with optical coherence tomography OCT to monitor changes in the epiretinal membrane and macular structure. Researchers measure the mean change in visual acuity letter score from baseline to 36 months as the primary outcome. The study also tracks visual distortion and reading speed to understand their usefulness in evaluating ERM. Safety and progression are closely monitored during the three-year follow-up period.

Researchers are evaluating a new medicine called PF-08634404 combined with chemotherapy for adults with colorectal cancer that has spread to other parts of the body. The study aims to understand how well this new combination works compared to an existing treatment using Bevacizumab with chemotherapy. The study is a phase 3, double-blind, randomized trial focusing on treatment effectiveness and safety in participants who have not received prior systemic therapy for metastatic disease. Participants are randomly assigned to one of two groups. One group receives PF-08634404 with chemotherapy, and the other group receives Bevacizumab with chemotherapy. Both treatments are given through intravenous IV infusions in cycles. Treatment continues as long as it helps and side effects are manageable. Treatments are administered at clinical sites by trained staff. Participants will have regular visits for treatment, health evaluations, and various tests. After stopping treatment, there is a follow-up visit about 30 to 37 days later to review health and side effects. Further follow-up occurs every 12 weeks by phone, in person, or via health record review to monitor health status and any new treatments. The study duration for each participant is approximately 33 months. Researchers will measure progression-free survival, overall survival, response rates, quality of life, and monitor safety throughout the study.