New Braunfels

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

This research evaluates and compares perioperative data in adults who have undergone emergent or urgent appendectomy surgery for acute appendicitis. The study is retrospective and focuses on surgeries performed using either robotic-assisted or laparoscopic methods. The purpose is to analyze short-term outcomes following these surgical procedures. Participants underwent either robotic-assisted or laparoscopic appendectomy for acute appendicitis. The surgeries were emergent or urgent and took place between 2018 and 30 days before the study's institutional review board approval. This study collects data on key surgical and postoperative details such as operative and procedure times, conversion rates, and estimated blood loss. Throughout the study, researchers review outcomes including adverse events during and after surgery up to 30 days, mortality rates within 30 days, unplanned readmissions and reoperations, length of hospital stay, discharge disposition, and blood transfusions. The study carefully measures severity of appendicitis before surgery and concomitant procedures during surgery. Participants' hospital discharge information and follow-up data are included to provide a comprehensive view of short-term surgical outcomes.

Researchers are investigating the effects of sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132) compared to standard treatments in people with previously treated extensive stage small cell lung cancer (ES-SCLC). The main goal is to compare how SG versus standard care impacts overall survival up to 4.5 years after treatment. This phase 3, global, multicenter, randomized, open-label study focuses on participants who have already received prior platinum-containing chemotherapy. Participants are randomly assigned to receive either sacituzumab govitecan or one of the standard care drugs, including topotecan, amrubicin (in Japan only), or lurbinectedin (where approved). All drugs are given by intravenous infusion. The study includes a treatment period where these medications are administered according to the protocol, with doses and schedules managed by the study teams. During the study, participants will be monitored regularly for overall survival and other health outcomes. Assessments will include imaging scans like CT or MRI to measure disease status, along with clinical evaluations and symptom monitoring. The study tracks safety and treatment effects over time, aiming for a follow-up of up to 4.5 years. Participants will have their condition reviewed throughout to evaluate how the treatments impact their survival and disease progression.

Researchers are evaluating overall survival in patients with advanced metastatic or locally recurrent breast cancer who have no approved treatment alternatives. This Phase 3, multicenter, randomized, open-label study compares the Bria-IMT regimen combined with the checkpoint inhibitor Retifanlimab against treatment chosen by patients or physicians. The study also aims to assess the activity of the Bria-IMT regimen alone compared to its combination with the checkpoint inhibitor. Participants are initially randomized equally into three groups: Bria-IMT plus Retifanlimab, treatment of physician's choice (TPC), and Bria-IMT alone. After enrollment of 150 patients, the monotherapy group is discontinued, allowing crossover to combination therapy if needed, with subsequent randomization continuing between combination therapy and TPC. Treatment cycles for Bria-IMT with or without Retifanlimab occur every three weeks, including cyclophosphamide given 2-3 days before SV-BR-1-GM inoculations, SV-BR-1-GM administered intradermally, interferon injections at inoculation sites, and Retifanlimab infusions timed consistently each cycle. TPC is given according to standard care at each site using approved drugs including chemotherapy and targeted agents. Participants undergo imaging assessments every six weeks twice, then every eight weeks during treatment if disease is stable and no major safety issues arise. Safety and overall survival will be monitored up to 60 months. Eligibility requires confirmation of advanced breast cancer with prior therapies failed, and participants must have an ECOG performance status of 0 to 2 with expected survival of at least four months. The study includes comprehensive assessments, treatment monitoring, and long-term follow-up to evaluate outcomes and safety.

Researchers are studying a new medicine called PF-08634404 to see how well it works when combined with chemotherapy in adults who have extensive-stage small cell lung cancer (ES-SCLC), a fast-growing cancer that has spread widely in the body. This study includes two parts: the first checks the safety and tolerability of PF-08634404 with chemotherapy, and the second compares PF-08634404 plus chemotherapy to another approved treatment, atezolizumab plus chemotherapy, to determine which is more effective. Participants will receive treatments through intravenous (IV) infusions in repeated cycles. Some will continue with PF-08634404 alone after the initial combined treatment. The study involves two phases: Phase 2 focuses on safety and response rates, while Phase 3 evaluates overall survival. Treatments are given according to a schedule during these phases to monitor effects. During the study, participants will undergo medical tests to assess organ function and cancer response, including measuring tumor lesions. Researchers will track treatment-related side effects for up to 90 days after the last dose and follow overall survival for up to about two years after treatment ends. The total involvement includes assessments throughout treatment and extended follow-up to evaluate safety and effectiveness.