Schaffhausen

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 treatments for patients with clinically node positive breast cancer who undergo upfront surgery. The study aims to compare tailored axillary surgery (TAS) combined with axillary radiotherapy (ART) against the standard axillary lymph node dissection (ALND) to see which approach results in better arm-related quality of life and fewer cases of lymphedema two years after treatment. This trial addresses the concern that ALND, while standard, can cause significant harm and morbidity, and seeks to determine if TAS plus ART can reduce this burden. Participants are randomly assigned to receive either ALND, which involves surgical removal of lymphatic tissue in the armpit area, or the combination of TAS and ART. TAS targets positive lymph nodes more selectively than ALND and removes fewer nodes, while ART involves radiation treatment to the axillary region. The trial is conducted in the upfront surgery setting, with prior clipping of the most suspicious axillary lymph node to aid in treatment precision. During the study, participants will complete quality of life questionnaires and be closely monitored for the development of lymphedema over two years following randomization. The main outcomes measured are changes in arm-related quality of life and the occurrence of lymphedema. Safety and treatment effects will be tracked through regular follow-up visits, with the overall goal of improving patient well-being and reducing treatment-related side effects.

Researchers are evaluating the effects of different virtual landscape environments on gait therapy for older adults with gait instability. The study focuses on how urban, rural, and forest virtual landscapes may help reduce stress, restore attention, and improve walking performance. This pilot randomized controlled trial aims to identify which types of landscapes best support restoration and contribute to improved gait stability in older people receiving gait therapy as inpatients. Participants will be randomly assigned to either a control group receiving standard gait therapy or intervention groups that receive five additional virtual reality (VR) training sessions over 10 days. During each 25-minute session, participants will wear a head-mounted display (HMD) and first view the assigned landscape (urban, rural, or forest) while seated for 5 minutes, followed by 20 minutes of independent walking exploration within the virtual environment. Walking aids may be used based on individual gait stability. The study uses a commercially available VR system with eye-tracking to provide immersive, safe, and motivating training environments. Throughout the study, participants will undergo various assessments including heart rate variability, electrodermal activity, gait measurements, eye-tracking, and interviews to evaluate stress levels, attention restoration, landscape perception, and balance confidence. The primary outcome is gait stability measured at the start and end of the intervention. This research aims to understand how virtual landscapes influence physical and psychological factors linked to gait improvement, with the goal of enhancing rehabilitation approaches for older adults with gait insecurity.