Frattamaggiore

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating whether valproic acid can improve the effectiveness of anti-EGFR treatments and help prevent or reverse resistance in patients with advanced or metastatic colorectal cancer who have RASBRAF wild-type tumors. This randomized phase 2 study includes patients eligible for a rechallenge treatment setting, aiming to better understand tumor responses and identify biomarkers through tissue and blood sample analysis. Participants will be randomly assigned to receive either standard treatment with irinotecan and panitumumab or the same treatment combined with valproic acid VPA. Irinotecan and panitumumab are given every two weeks, while VPA is taken orally daily with dose adjustments to reach target blood levels. The study includes a safety phase for the VPA combination, and treatment continues until disease progression, unacceptable side effects, or other reasons for stopping. Throughout the study, patients will undergo tumor assessments by CT or MRI scans every 8 weeks, blood tests, and quality of life questionnaires. Toxicities will be monitored during treatment and up to 4 weeks after. Blood and tissue samples will be collected to study biomarkers related to treatment response and side effects. Follow-up will continue until death, recording subsequent treatments, with the primary outcome measuring progression-free survival at 16 weeks.