Hardeeville

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

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.