Sankt Veit An Der Glan

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are investigating whether neoadjuvant endocrine therapy is at least as effective as neoadjuvant chemotherapy for treating patients with early or locally advanced estrogen receptor-positive and HER2-negative breast cancer who have no detectable circulating tumor DNA ctDNA before treatment and show endocrine responsiveness. This phase II performance study focuses on comparing these treatments effectiveness, measured by the modified preoperative endocrine prognostic index PEPI score at surgery, while also considering quality of life outcomes. Participants first provide blood and tumor samples for ctDNA assessment using the SignateraTM test. They then receive aromatase inhibitor AI therapy for 4 weeks during a Run-in phase, with a tumor biopsy after 3 weeks to evaluate Ki-67 levels. Based on ctDNA results and Ki-67 values, participants are assigned to one of three groups neoadjuvant AI or tamoxifen if AI is not tolerated for responders, or chemotherapy for non-responders. The Main Treatment Phase lasts 6 to 8 months, followed by surgery and a 5-year follow-up period. Throughout the study, participants attend multiple clinic visits for checkups, blood draws for ctDNA monitoring, and questionnaires about quality of life, symptoms, and sexual health. Key assessment points include before treatment start, after 3 weeks of AI therapy, prior to the Main Treatment Phase, mid-therapy, post-treatment, surgery, and annual follow-ups. Some participants receiving adjuvant chemotherapy have an additional visit after completing chemotherapy. The study evaluates several outcomes including PEPI score, residual cancer burden, survival measures, and breast conservation rates.

Researchers are investigating the efficacy and safety of duvakitug in people with moderately to severely active Crohns Disease in a multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. The trial includes three sub-studies aiming to evaluate duvakitugs effects compared to placebo during induction treatment phases, focusing on clinical remission and endoscopic response at 12 weeks. Participants receive subcutaneous injections of duvakitug or placebo following the study protocol. The study duration can be up to 35 weeks, including a screening period of up to 5 weeks, followed by a 12-week induction phase in either Sub-Study 1 open-label, Sub-Study 2 pivotal induction, or Sub-Study 3 extended induction for non-responders. A 6-week follow-up period applies to participants not entering the maintenance study. Throughout the trial, participants undergo scheduled visits for assessments including clinical remission based on Crohns Disease Activity Index and endoscopic scores. Safety is monitored with reports of adverse events and serum drug levels. Up to 8 to 15 visits are planned depending on the sub-study, with follow-up continuing for 45 days after the last dose for those not moving to maintenance treatment.