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Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating whether neoadjuvant endocrine therapy is at least as effective as neoadjuvant chemotherapy for treating patients with early and locally advanced estrogen receptor-positive (ER+), HER2-negative breast cancer who show no detectable circulating tumor DNA (ctDNA) in their blood and have a low Ki-67 value after initial therapy. This phase II, prospective, randomized, controlled, open-label study focuses on participants whose tumors respond to endocrine therapy, aiming to compare treatment effectiveness and quality of life outcomes between the two approaches. Participants first undergo a 4-week Run-in phase taking aromatase inhibitors (or tamoxifen if aromatase inhibitors are not tolerated) while providing blood and tumor samples for ctDNA assessment and Ki-67 analysis. Based on these results, they are assigned to one of three treatment arms: neoadjuvant endocrine therapy (aromatase inhibitors or tamoxifen), neoadjuvant chemotherapy, or chemotherapy if ctDNA is detected or Ki-67 is high. The main treatment phase lasts 6 to 8 months, followed by surgery. Throughout the study, participants attend clinic visits before treatment, during the Run-in phase, before the main treatment, mid-treatment, after completing therapy, at surgery and post-surgery, and annually for five years. They provide blood samples for ctDNA analysis, undergo biopsies, and complete questionnaires about quality of life, symptoms, and sexual health. The primary outcome measured is the modified Preoperative Endocrine Prognostic Index (PEPI) score from randomization to surgery.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.