Schwaz

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

This research aims to compare two different types of screws used in surgery to repair a torn anterior cruciate ligament (ACL) in the knee, a common injury especially in young adults active in sports. The study focuses on whether a human allogeneic cortical bone screw (Shark Screw ACLae) reduces the widening of bone tunnels created during surgery compared to a standard biocomposite screw (MectaScrew). The trial also evaluates re-rupture rates and collects knee function scores before and after surgery to better understand the outcomes of these two fixation methods. Participants are randomly assigned to receive ACL reconstruction using either the Shark Screw ACLae or the biocomposite screw. Both types of screws are used to fix the new ligament graft in place within bone tunnels in the femur and tibia. The surgical method and treatment plans are the same for both groups except for the type of screw used. The study is single-blind and conducted at a single center, aiming to enroll 80 patients, with 40 in each treatment group. Participants undergo MRI scans before surgery, immediately after surgery, and at 3, 6, 12, and 24 months post-surgery to assess bone tunnel widening. CT scans are performed immediately after surgery, and at 3, 6, and 24 months. Knee function questionnaires are completed before surgery and at 6, 12, and 24 months afterward. The main outcome measured is the degree of bone tunnel widening over time. The safety, incorporation, and effectiveness of the allogeneic bone screw are also assessed throughout the 24-month follow-up period.

Researchers are evaluating treatments for advanced breast cancer characterized by estrogen receptor-positive, HER2-negative, and ESR1-mutated tumors. This study focuses on patients whose cancer has progressed despite previous endocrine therapy and CDK4/6 inhibitor treatment. The goal is to determine the effectiveness of combining elacestrant, a selective estrogen receptor degrader, with everolimus, a kinase inhibitor, compared to elacestrant with a placebo. This phase 3 trial aims to assess how well these treatments prolong the time patients live without disease progression or unacceptable side effects. A total of 240 patients will be randomly assigned to one of two groups: one receiving 345 mg of elacestrant plus 7.5 mg of everolimus daily, and the other receiving 345 mg of elacestrant plus a placebo daily. Treatment cycles last 28 days and continue until disease progression, unacceptable toxicity, death, or other reasons for stopping. Patients will be grouped based on the presence of visceral metastases and prior duration of CDK4/6 inhibitor therapy. After stopping treatment, patients enter a follow-up period where survival and new cancer therapies are tracked every three months for up to 12 months after the last patient is enrolled. Participants will undergo regular assessments including imaging scans to monitor cancer status and safety evaluations. The main measure is progression-free survival, defined as the time from treatment start until tumor progression, death, or discontinuation for other reasons, monitored on average for 12 months. Safety and treatment effectiveness will be closely followed throughout the study, with additional tumor assessments for those who stop treatment for reasons other than progression until new cancer therapy begins, death, or disease progression occurs.

Researchers are evaluating the use of vacuum-assisted biopsy (VAB) as a less invasive method to detect residual tumor tissue in breast cancer patients who have undergone neoadjuvant chemotherapy (NAC). NAC is commonly used to shrink tumors before surgery and can lead to complete pathologic remission in over half of aggressive breast cancer types. However, current imaging methods like ultrasound, mammography, and MRI are not reliable enough to confirm if the tumor has been fully eliminated, so surgery remains necessary to assess or remove any remaining disease. In this trial, patients who show a radiological complete or near-complete response after NAC will undergo VAB guided by ultrasound or mammography immediately before their scheduled breast surgery. This biopsy procedure aims to collect tissue samples from the former tumor site to better detect any residual cancer cells. The accuracy of this biopsy will then be compared to the standard surgical tissue analysis to evaluate if VAB can serve as a reliable pre- or intra-operative tool. Participants will be involved in diagnostic imaging and biopsy procedures shortly before their routine breast surgery. Researchers will assess the sensitivity of the VAB in detecting residual tumor tissue within six weeks after patient registration. The study includes monitoring of biopsy results against surgical pathology findings to determine VAB's diagnostic value. Participants must meet specific eligibility criteria and will be followed closely during the trial to ensure safety and accurate data collection.