Gelsenkirchen

This observational study follows patients with relapsing multiple sclerosis RMS who are being treated with approved injectable or selected oral disease-modifying therapies DMTs in Germany. The study is non-interventional and open-label, designed to collect real-world data on treatment and disease progression over several years. It aims to understand how patients continue their baseline treatments and how these treatments impact various health and quality of life measures. Participants receive routine medical care with approved injectable or oral DMTs such as ofatumumab, interferon b21, glatiramer acetate, teriflunomide, dimethyl fumarate, or diroximel fumarate. The study includes two cohorts with up to approximately two years of prospective observation each, with an optional extension allowing up to four years total. Treatment decisions and monitoring follow the patients usual care and physicians discretion, including routine visits and telemedicine options. During the study, participants provide medical history, complete questionnaires, and have data collected on disability status, MRI findings, relapses, and laboratory tests. Researchers assess treatment continuation rates, fatigue, anxiety, depression, quality of life, lesion counts, and relapse rates at multiple time points. Safety and treatment interruptions are also documented. Follow-up is flexible and based on standard care procedures, with data collection occurring throughout the observational periods.

Researchers are studying the use of ribociclib, a CDK46 inhibitor, in women with early hormone receptor-positive HR and HER2-negative breast cancer who are at intermediate risk of cancer recurrence. The study aims to see if patients can avoid chemotherapy, which has significant side effects, by using ribociclib along with hormone therapy after surgery. This phase III trial builds on the NATALEE study, which showed that ribociclib added to hormone therapy improved survival free of invasive disease in similar patients. Participants will be randomly assigned to one of two groups one receiving ribociclib plus endocrine hormone therapy, and the other receiving chemotherapy followed by ribociclib and endocrine therapy. Ribociclib treatment lasts for three years, and chemotherapy is given before starting ribociclib and hormone treatment. The trial aims to compare the outcomes of chemotherapy de-escalation versus standard treatment in this patient group. During the study, participants will attend scheduled visits for treatment and monitoring, including laboratory tests, heart monitoring with ECG, and questionnaires about their quality of life. Researchers will track invasive breast cancer-free survival and other outcomes such as overall survival and treatment side effects for up to 12 years. Safety and quality of life assessments will continue during and after treatment to evaluate the long-term effects and benefits of the treatment approaches.

Triple negative breast cancer TNBC is a type of breast cancer that lacks certain receptors and tends to have a poor prognosis and aggressive behavior. The study focuses on patients with low-risk, early-stage TNBC stage I-II node-negative who generally have better outcomes, but still face significant clinical challenges. Researchers are evaluating neoadjuvant therapies to improve treatment strategies for this group, especially comparing sacituzumab govitecan alone versus its combination with pembrolizumab. Participants will receive neoadjuvant treatment for 12 weeks, either sacituzumab govitecan alone or combined with pembrolizumab. Sacituzumab govitecan is given intravenously at 10 mgkg on Days 1 and 8 every 21 days, while pembrolizumab is administered intravenously at 200 mg every three weeks. Depending on their response after 12 weeks, some patients may continue treatment for an additional 6 weeks before surgery. Patients who achieve a complete response may not require further systemic treatment, while those with residual disease may receive additional chemotherapy as decided by their investigator. Throughout the study, participants will be closely monitored with various assessments including pathological evaluation at surgery and invasive disease-free survival measured after three years. Other outcomes include overall survival and quality of life assessments. Safety and response will be regularly evaluated to guide treatment decisions. The trial aims to enroll adult women with early-stage TNBC and will continue through September 2029, with detailed follow-up planned to capture long-term outcomes.

Researchers are evaluating whether the combination of sacituzumab govitecan-hziy SG and pembrolizumab given after surgery is effective and safe compared to the treatment of physicians choice TPC in adults with triple negative breast cancer that remains after surgery and pre-surgical therapy. This phase 3 trial focuses on participants who have residual invasive disease following neoadjuvant therapy and surgery. The study aims to better understand outcomes for this condition where cancer persists despite earlier treatments. Participants are randomly assigned to one of two groups. One group receives SG intravenously at 10 mgkg on Days 1 and 8 of 21-day cycles along with pembrolizumab 200 mg intravenously on Day 1, repeated for up to 8 cycles. The other group receives physicians choice treatment pembrolizumab alone or pembrolizumab combined with oral capecitabine, also given over 8 cycles. Treatment continues until 8 cycles are completed, disease recurrence, unacceptable side effects, or other specified reasons. During the study, participants are monitored for invasive disease-free survival up to 60 months, along with overall survival, distant disease-free survival, recurrence-free survival, and quality of life measures. Safety is assessed through tracking treatment-related adverse events and laboratory tests for up to 38 months plus 30 days. This long-term follow-up helps evaluate the impact of the treatments on disease outcomes and participant well-being.