Nyack

Researchers are evaluating treatments for people with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) breast cancer that cannot be removed by surgery or has spread to other parts of the body. This study compares sacituzumab tirumotecan alone and in combination with pembrolizumab to the Treatment of Physician's Choice (TPC). The goal is to see which approach better controls disease progression based on specific tumor response criteria. Participants are assigned to one of three groups: one group receives sacituzumab tirumotecan intravenously every two weeks, another group receives the same drug plus pembrolizumab intravenously every six weeks for up to about two years, and the third group receives chemotherapy chosen by the doctor, which may include various drugs administered either by infusion or orally. Treatments continue until the disease worsens or participants stop treatment. During the study, participants undergo regular assessments to monitor how well treatments control cancer progression, overall survival, and response to therapy. Quality of life and physical and emotional functioning are also measured using specific questionnaires. Safety is closely watched by tracking any side effects or reasons for stopping treatment. The study lasts up to several years, with some outcomes followed for up to about six years after starting treatment.

Researchers are evaluating the effectiveness and safety of different ibrutinib treatment plans, alone or combined with venetoclax, for people with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. This Phase 2 study compares regimens where ibrutinib dosing is either proactively reduced or adjusted in response to side effects. The goal is to find the best way to customize treatment while monitoring responses and adverse events. Participants receive ibrutinib capsules daily for a lead-in period of three 28-day cycles. Starting with cycle 4, some groups add venetoclax tablets with a gradual dose increase over five weeks, continuing both drugs daily for 12 cycles, while others continue ibrutinib alone at either the full or a reduced dose until disease progression or unacceptable side effects. Four different treatment arms explore these variations, including fixed duration and continuous therapy options. During the study, participants undergo regular evaluations to monitor cancer response, side effects, and quality of life for up to five years. Assessments include imaging scans to measure lymph nodes, blood tests, and questionnaires about symptoms and fatigue. Researchers track outcomes like overall response rate, survival, adverse events, treatment adherence, and changes in health status over time to understand the impact of each treatment plan.

Researchers are conducting the FLEX Registry, a large-scale, population-based study focusing on patients with stage I to III breast cancer who have undergone MammaPrint and BluePrint testing on their primary breast tumors. This observational registry aims to gather comprehensive full genome expression data linked with clinical information to explore new gene associations that may have prognostic or predictive value. The design is adaptive, allowing additional targeted substudies and arms to be added over time for more specific investigations. All participants will have their tumor samples tested using MammaPrint and BluePrint through the full-genome testing array provided by Agendia. Treatment decisions are made by the treating physician following NCCN guidelines or recognized alternatives, with no specific treatment mandated by the study. The registry plans to enroll about 30,000 patients from more than 125 US institutions, encompassing various treatment arms detailed in study appendices. Participants will have clinical data collected online at multiple time points: at enrollment, during treatment, and at 1, 3, 5, and 10 years after diagnosis. This long-term follow-up allows researchers to study gene expression alongside clinical outcomes, supporting the creation of subgroup analyses and future targeted trials. The primary outcomes include establishing a large-scale full genome expression registry and providing infrastructure for examining smaller patient groups over the 10-year study period.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

This research aims to compare the effects of regional radiotherapy versus no regional radiotherapy in women with low-risk breast cancer who are receiving usual care. The study focuses on women with node-positive or T3N0 breast cancer who have undergone breast-conserving surgery or mastectomy, to see if avoiding regional radiotherapy works as well at preventing the cancer from returning. Participants receive either whole breast irradiation with or without regional radiotherapy to lymph nodes after surgery, or no regional radiotherapy following mastectomy or breast-conserving surgery. The study involves random assignment to these treatment groups and evaluates the impact of adding or omitting regional radiotherapy as part of their care. During the study, researchers will monitor breast cancer recurrence-free interval over 9.5 years, along with other outcomes such as invasive disease-free survival, mortality, overall survival, and quality of life. Patient-reported outcomes, arm mobility, adverse events, and cost-effectiveness are also assessed. Treatment adherence, follow-up visits, and collection of tumor tissue and blood samples are part of the participant's involvement throughout the trial.

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 examining the interests and motivations of people living with psoriatic arthritis (PsA) regarding participation in wellness activities. This observational survey study, supported by Janssen and the Cleveland Clinic, aims to identify barriers and facilitators that affect patient engagement in guided online wellness programs. The study focuses on understanding how patients manage their disease and make lifestyle decisions that may improve treatment outcomes. Participants who qualify will complete a 10-minute survey and may be invited to join Immune Strength, a free, 10-week online wellness program developed by the Cleveland Clinic. This program is designed to help participants build healthier habits that support a more resilient immune system. Participation involves guided behavior changes and strategies for improving immune health. During the study, participants will be recruited primarily from the ArthritisPower registry and other arthritis patient communities. Researchers will measure interest in wellness programs and identify barriers to participation through survey responses on day 1. Participants must have access to digital devices to complete the survey and engage with the program. The study helps inform clinicians and researchers about patient needs related to wellness activities in PsA management.

Researchers are studying a new medicine called PF-08634404 to see how well it works for adults with colorectal cancer that has spread to other parts of the body. This trial aims to find out if combining PF-08634404 with approved chemotherapy helps compared to using another approved medicine, Bevacizumab, combined with chemotherapy. The study is a phase 3, double-blind, randomized trial focused on treatment-nafve participants with metastatic colorectal cancer. Participants will be randomly assigned to one of two groups: one group will receive PF-08634404 plus chemotherapy, and the other will receive Bevacizumab plus chemotherapy. Both treatments are given through intravenous (IV) infusions at a clinical site. Treatments are given in cycles, and participants can continue treatment as long as it is helping and side effects are manageable. During the study, participants will have regular visits for treatment, health checks, and tests. After stopping treatment, there will be a final visit about 30 to 37 days later to evaluate health and side effects. Follow-up will continue every 12 weeks by phone, in person, or by reviewing health records. The study is expected to last about 33 months per participant. Researchers will measure outcomes like progression-free survival and overall survival over approximately 4 years, along with response rates, duration of response, quality of life, and safety assessments.

Researchers are evaluating the new medicine PF-08634404 combined with chemotherapy compared to the current standard treatment pembrolizumab with chemotherapy for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC). This phase 3, double-blind, randomized study focuses on adults 18 years or older with squamous or non-squamous NSCLC who are not candidates for surgery or curative chemoradiotherapy and who have not received prior treatment for advanced disease. Participants are divided into two parts based on tumor type: squamous NSCLC (Part 1) and non-squamous NSCLC (Part 2). Each participant is randomly assigned to receive either PF-08634404 or pembrolizumab along with a chemotherapy regimen specific to their tumor type. Treatments are given through intravenous infusions in cycles, with maintenance therapy continuing if the treatment is effective and side effects are manageable. Throughout the study, participants will attend regular visits for treatment administration and health monitoring. Cancer response will be assessed every 6 weeks during the first 48 weeks, then every 12 weeks thereafter. Researchers will measure overall survival, progression-free survival, response rates, quality of life, and safety through various assessments including imaging, laboratory tests, and questionnaires over approximately 32 to 39 months of follow-up.

Researchers are evaluating the addition of pembrolizumab, an immunotherapy drug, to usual chemotherapy for patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer that has been completely removed by surgery. This phase III trial aims to compare disease-free survival and overall survival between different treatment approaches, including chemotherapy alone and chemotherapy combined with pembrolizumab. The study also assesses quality of life, side effects, and the impact of tumor markers on outcomes. Patients are randomly assigned to one of two active treatment groups. One group receives standard chemotherapy every 21 days for 4 cycles followed by pembrolizumab given intravenously every 21 days or every 6 weeks for up to 17 cycles. The other group receives chemotherapy combined with pembrolizumab during the initial 4 cycles, followed by pembrolizumab alone for additional cycles. Chemotherapy regimens include combinations of cisplatin, carboplatin, pemetrexed, gemcitabine, or paclitaxel. A previous group receiving chemotherapy alone followed by observation is closed. Participants undergo various assessments including echocardiograms, MRIs, CT scans, and blood sample collections during the trial. They complete quality of life questionnaires and are monitored regularly for disease recurrence, side effects, and survival for up to 10 years. Follow-up visits occur every 3 months for 2 years, then every 6 months for years 2 to 4, and annually thereafter, providing long-term monitoring of treatment effects and safety.