Frattamaggiore

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating patients who have experienced athero-thrombotic events such as coronary artery disease, cerebrovascular disease, or peripheral artery disease. The study aims to assess how well patients follow guideline recommendations, particularly focusing on improving cholesterol levels and other modifiable risk factors to reduce the chance of cardiovascular event recurrence. This observational and prospective study takes place across multiple cardiology centers in Italy to represent a broad patient population. The study includes several phases starting with an educational intervention to discuss guideline recommendations for secondary prevention. Following this, data is collected for three months or until 30 patients with documented cardiovascular conditions are enrolled, using a web-based case record form that identifies when guidelines are not followed and records reasons for non-adherence. After six months, primary and secondary outcomes are evaluated. A second educational intervention then shares findings from the first phase to highlight gaps in clinical practice, followed by another three-month data collection period and a further six-month outcome assessment. Finally, all patients are followed for 12 months to monitor longer-term results. Participants provide informed consent and are monitored through data collection forms that track adherence to guidelines and clinical outcomes. The main outcome measured is adherence to cholesterol management guidelines over six months. Additional assessments include adherence to recommendations for other cardiovascular risk factors. Throughout the study, researchers gather data to understand how guideline adherence affects patient health and to identify barriers to following best practices, with continuous follow-up over a year to evaluate sustained effects.

Researchers are evaluating whether the drug valproic acid (VPA) can enhance the effect of anti-EGFR treatments and prevent or reverse resistance to these therapies in patients with advanced or metastatic colorectal cancer that is RAS/BRAF wild-type. This phase 2, open-label, randomized study focuses on patients eligible for rechallenge therapy, meaning they have received at least two prior treatment lines and show specific genetic markers in their blood. The trial aims to understand tumor changes and identify biomarkers that predict treatment response through tissue and blood sample analysis. Participants will be randomly assigned to one of two treatment groups. One group receives standard treatment with irinotecan and panitumumab every two weeks, while the other group receives valproic acid daily along with the same irinotecan and panitumumab regimen. Valproic acid dosing starts with gradual escalation to reach a target blood level known from epilepsy treatment and preclinical studies. After initial safety checks in the valproic acid group, treatment continues until disease progression, unacceptable side effects, or other stopping reasons. Patients completing treatment enter a follow-up phase where their health is monitored until death. Throughout the study, patients undergo regular tumor assessments every 8 weeks using CT or MRI scans and blood tests for tumor markers. Side effects are tracked at every visit and for four weeks after treatment ends using standardized criteria. Patients also complete quality of life and symptom questionnaires at baseline and every 8 weeks. Blood and tissue samples collected at multiple times help researchers study treatment effects and toxicity. The main outcome measured is progression-free survival at 16 weeks, comparing the two treatment arms. Participants remain in the study until death, with data collected on subsequent treatments for comprehensive evaluation.