Schwaz

Researchers are evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

This trial studies adults with anterior cruciate ligament ACL rupture who need reconstructive surgery. It compares two types of screws used for fixing the graft during ACL reconstruction a human allogeneic cortical bone screw called Shark Screw ACL and a conventional biocomposite screw Mecta. The goal is to see if the bone screw reduces bone tunnel widening and lowers the rate of graft re-rupture. Knee function scores before and after surgery are also recorded to assess outcomes. Participants undergo ACL reconstruction with either the allogeneic bone screw or the biocomposite screw. The surgical technique is the same for both groups, including arthroscopic confirmation of diagnosis, tendon preparation, bone tunnel creation, graft insertion, and fixation with the assigned interference screw. The tibial bone tunnel is filled with cancellous chips, and graft stability is checked before wound closure. Participants have MRIs before surgery, within 3 days after surgery, and at 6, 12, and 24 months post-surgery. CT scans are done immediately after surgery, and at 6 and 24 months. Knee scores IKDC, KOOS, Lysholm, Tegner are collected before surgery and at 6, 12, and 24 months. The study measures bone tunnel widening in millimeters over time and evaluates graft incorporation, safety, and knee function. Total participation lasts 24 months after surgery.

Researchers are evaluating a treatment for advanced breast cancer that is estrogen receptor-positive, HER2-negative, and has a specific ESR1 gene mutation. The study aims to find out how well a combination of elacestrant, a selective estrogen receptor degrader, and everolimus, a kinase inhibitor, works in patients whose cancer has progressed despite prior endocrine therapy and CDK46 inhibitor treatment. The study follows strict guidelines to ensure patient safety and compliance with international clinical standards. Participants will be randomly assigned to one of two groups. One group will receive elacestrant at 345 mg plus everolimus at 7.5 mg orally once daily, while the other group will receive elacestrant at the same dose plus a placebo instead of everolimus. Treatments will be given in 28-day cycles and continue until disease progression, unacceptable side effects, or other reasons for stopping the treatment occur. After stopping treatment, patients will be followed every three months for up to one year to monitor survival and any new cancer therapies. During the study, patients will undergo scans such as CT or MRI to confirm disease status, and tests to assess tumor markers and gene mutations. Researchers will monitor treatment effects, safety, and quality of life using questionnaires like the EQ-5D-5L and EORTC QLQ-C30 and QLQ-BR42. Side effects, blood counts, liver and kidney function, heart activity, and overall health status will be regularly checked. The main outcome is progression-free survival, measuring how long patients live without cancer worsening during treatment, with other outcomes including overall survival and treatment response. The total study duration for each participant averages about 12 months.

Researchers are studying the use of vacuum-assisted biopsy VAB to better detect remaining breast cancer tissue after neoadjuvant chemotherapy NAC, which is a common initial treatment for breast cancer. NAC can lead to complete disappearance of the tumor in aggressive cancer types, but current imaging methods cannot reliably predict if any cancer remains. This study aims to compare the accuracy of tissue samples taken by VAB before surgery to the standard surgical tissue samples to see if VAB can serve as a less invasive way to check for residual cancer. Participants will undergo ultrasound- or mammography-guided VAB to sample tissue from the former tumor site after NAC and before standard breast surgery. The trial focuses on patients with certain breast cancer types who show a complete or near-complete response on imaging after chemotherapy. After the biopsy, participants will have breast conserving surgery or mastectomy, and both biopsy and surgical samples will be examined to evaluate the presence of residual cancer. During the study, patients will be monitored closely with imaging before VAB and surgery, and the tissue samples will be analyzed for residual disease. Researchers will measure how accurately VAB detects residual cancer compared to surgery by assessing sensitivity, specificity, and predictive values. Safety will be monitored from the biopsy until two weeks after surgery. The total time from registration to outcome measurement is up to six weeks.