New Braunfels

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

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 research aims to compare short-term outcomes in adults who have undergone emergency or urgent appendectomy for acute appendicitis. The study evaluates two surgical approaches robotic-assisted and laparoscopic appendectomy. It is a retrospective observational study analyzing data collected from 2018 up to 30 days before IRB approval. Participants are divided into two groups one includes about 500 subjects who had robotic-assisted appendectomy, and the other about 500 subjects who had laparoscopic appendectomy. The study collects data in reverse chronological order from the specified timeframe. Both surgical methods are studied as procedures for treating acute appendicitis. Researchers review surgical and recovery information, including operative and procedure times, conversion rates, adverse events, mortality within 30 days, unplanned readmissions and reoperations, blood loss, severity of appendicitis, length of hospital stay, discharge disposition, and blood transfusions. The study covers the period from surgery until discharge and up to 30 days afterward, focusing on short-term outcomes.

Researchers are evaluating the study drug sacituzumab govitecan SG Trodelvy GS-0132 IMMU 132 compared to standard of care SOC treatments in participants who have previously been treated for extensive stage small cell lung cancer ES-SCLC. The main goal is to compare how SG versus SOC affects overall survival OS in this population. This is a global, multicenter, randomized, open-label, phase 3 clinical trial focusing on treatment outcomes for ES-SCLC. Participants are randomly assigned to one of two groups. Treatment Group A receives sacituzumab govitecan intravenously at 10 mgkg on Days 1 and 8 of a 21-day cycle, continuing until disease progression, death, unacceptable toxicity, or other reasons for stopping treatment. Treatment Group B receives investigator-selected standard care options within a 21-day cycle, including topotecan given daily on Days 1 through 5, lurbinectedin as an intravenous infusion on Day 1 where approved, or in Japan, amrubicin daily on Days 1 through 3. Treatment continues under the same conditions as Group A. Participants will undergo regular assessments including imaging scans to measure disease status, laboratory tests, and monitoring for side effects. Researchers will evaluate overall survival for up to 4.5 years and secondary outcomes such as progression-free survival, response rates, duration of response, and effects on symptoms like shortness of breath and physical functioning. Safety will be tracked through adverse event reporting and laboratory abnormalities throughout the study duration.

Researchers are evaluating overall survival in patients with advanced metastatic or locally recurrent breast cancer who have no approved alternative therapies available. This Phase 3, multicenter, randomized, open-label study compares a new combination treatment called the Bria-IMT regimen plus a checkpoint inhibitor Retifanlimab against treatment chosen by patients and their physicians. The study also aims to assess the effectiveness of the Bria-IMT regimen alone compared to its combination with the checkpoint inhibitor. The study includes three initial groups one receiving Bria-IMT plus Retifanlimab, one receiving physicians choice treatment such as eribulin, carboplatin, capecitabine, gemcitabine, vinorelbine, or taxanes, and one receiving Bria-IMT alone. After enrolling 150 patients, the Bria-IMT alone group will be stopped, and those patients may switch to the combination therapy. Treatment cycles for Bria-IMT arms occur every three weeks, with imaging assessments every six weeks twice, then every eight weeks if no disease progression or safety concerns arise. Participants will undergo various assessments throughout the study, including imaging and clinical evaluations, to track overall survival up to 60 months. Secondary outcomes include progression-free survival, clinical benefit rate, overall response rate, quality of life, and central nervous system event-free survival. Safety and treatment effects will be monitored continuously, and participants may be followed for up to five years after starting treatment.

Researchers are evaluating a new medicine called PF-08634404 combined with chemotherapy in adults with extensive-stage small cell lung cancer ES-SCLC, a fast-growing type of lung cancer that has spread widely. The study aims to learn how well PF-08634404 works when given with chemotherapy compared to an approved treatment called atezolizumab plus chemotherapy. The study is conducted in two phases to assess safety, tolerability, and effectiveness of the treatments. Participants will receive treatments through intravenous IV infusions in repeated cycles. In the first phase, the focus is on safety and tolerability of PF-08634404 with chemotherapy. The second phase compares PF-08634404 plus chemotherapy to atezolizumab plus chemotherapy. Some participants may continue receiving PF-08634404 alone after the initial combination treatment. Treatments are delivered as IV infusions during scheduled cycles. During the study, participants will undergo medical tests to monitor their health and cancer status. Researchers will assess response rates, survival times, progression-free survival, and quality of life using standard measurement criteria. Safety will be closely monitored through tracking adverse events and laboratory tests. The study lasts up to around two years after the last participant completes treatment, with regular visits for assessments and follow-up.