Frejus

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 exploring a treatment approach for women with early-stage hormone receptor-positive, HER2-negative breast cancer who face an intermediate risk of cancer recurrence. This phase III trial builds on previous findings that adding the drug ribociclib, a CDK4/6 inhibitor, to standard hormone therapy after surgery can extend the time patients remain free from invasive disease. The study aims to see if using ribociclib allows some patients to avoid chemotherapy and its side effects without compromising treatment effectiveness. Participants will either receive chemotherapy followed by hormone therapy combined with ribociclib or a de-escalated treatment plan that reduces or omits chemotherapy while still using ribociclib and hormone therapy. Ribociclib will be administered for three years as part of the adjuvant treatment after surgery. The study is designed to reflect routine clinical practices for deciding chemotherapy eligibility, using standard pathological assessments and genomic tests. Throughout the trial, women will undergo regular monitoring, including clinical visits, laboratory tests, and heart function assessments, to ensure safety and treatment adherence. Researchers will measure invasive breast cancer-free survival over a period of up to 12 years from randomization. The study also tracks patients' ability to comply with treatment schedules and evaluates long-term outcomes to confirm if chemotherapy can be safely reduced or avoided in this group.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

Researchers are evaluating the use of an AI-assisted method for the second reading of screening mammograms compared to the standard second reading by radiologists. This study aims to determine if the AI-assisted approach is not worse than the standard method and if it offers economic advantages. Participants are women undergoing mammograms as part of the breast cancer screening program in France. The study involves two reading pathways for mammograms eligible for a second reading: the conventional second reading by an accredited radiologist (control arm) and the AI-assisted second reading (experimental arm) using the MammoScreen device. In the AI-assisted arm, the AI first reviews the mammogram, and only if it flags suspicion does a radiologist perform a second review. The final decision uses the more concerning result from either arm to determine if recall for further examination is needed. Participants will undergo screening mammograms with both reading processes applied. Researchers will compare diagnostic performance and economic impact between the two pathways, focusing on recall rates at the end of a 24-month inclusion period. Women will participate according to the breast cancer screening schedule and provide informed consent for study involvement.

Post-thrombotic syndrome (PTS) is a frequent long-term complication of deep vein thrombosis (DVT) that significantly affects patients' quality of life and increases healthcare costs. This research aims to study how the extent of blood clot burden in the veins, measured by a special ultrasound score called the Venous Volumetric Index (VVI), can predict the likelihood and severity of PTS six months after a first episode of symptomatic DVT in the lower limbs. Understanding these predictive factors could help guide better treatment strategies for patients at risk of developing PTS. The study is a multicenter prospective cohort design involving patients diagnosed with a first episode of symptomatic lower limb DVT confirmed by ultrasound. Participants will be followed with clinical assessments and ultrasound scans at one week (only for those in biological research), one month, three months, and six months after diagnosis. Blood samples will be collected at baseline, one week, one month, and three months to examine inflammation and blood clotting factors. Quality of life questionnaires will be completed at three and six months. The VVI score will be calculated from ultrasound data to quantify the clot burden, and the Villalta scale will be used to assess PTS severity over the six-month follow-up period. During each visit, symptoms and clinical signs related to PTS will be evaluated, and color Doppler ultrasound of the lower limbs will be performed. Blood tests will help explore biological markers linked to PTS development. Patients will complete questionnaires about their quality of life to assess the impact of symptoms. The study concludes with the six-month visit, at which point researchers will analyze the association between initial clot burden and PTS outcomes. This comprehensive follow-up aims to improve the prediction and understanding of PTS after DVT.

Researchers are evaluating the use of olaparib in adult male patients with metastatic castration-resistant prostate cancer (mCRPC) in a real-world setting across multiple centers in France. This observational longitudinal study aims to understand how olaparib is used in treatment sequences, its effectiveness, safety, and patterns of BRCA genetic testing to help improve future clinical care for this condition. The study includes patients who have started olaparib treatment within the last two months before joining the study or who participated in an early access program funded for olaparib use. Treatment decisions are made by the patients' physicians, and researchers observe and collect data without intervening. The study follows patients for up to 24 months from the start of olaparib treatment to track how long they continue the treatment and other outcomes. Participants will be monitored through their routine medical care, and data will be collected on treatment duration, safety, and BRCA testing patterns. The main outcome measured is the time until patients stop olaparib treatment, observed over a period of up to two years. The study relies on patient records and does not involve additional experimental procedures, focusing on real-life treatment experiences and outcomes.

Colorectal cancer mainly affects elderly patients, with over half of new cases in France occurring in those aged 70 or older. Adjuvant chemotherapy has shown benefits in disease-free and overall survival after stage III colon cancer surgery, but its use in elderly patients remains limited. This phase III randomized study explores whether adjuvant chemotherapy improves disease-free survival in elderly patients and which chemotherapy regimen is most effective, addressing concerns about benefits for both unfit and fit elderly patients. Participants will be divided into two groups based on a multidisciplinary evaluation including a geriatrician. One group will receive fluoropyrimidine-based chemotherapy (LV5FU2 or capecitabine), and the other will receive oxaliplatin-based chemotherapy (FOLFOX4 or XELOX). Some patients may be assigned to observation only. Treatments will begin within 12 weeks after surgery. The study also evaluates specific biological markers common in elderly tumors, such as mismatch repair deficiency. During the study, participants will undergo assessments including geriatric questionnaires and medical monitoring. Researchers will track disease-free survival over three years following the last patient's enrollment. Safety and treatment effects will be monitored, with exclusion of patients expected to live less than four years or those unable to comply with follow-up. The study aims to better understand chemotherapy benefits in an elderly population after colon cancer surgery.

This research aims to observe patients in France who have HER2-negative early breast cancer and are treated with olaparib. The study focuses on understanding how many patients complete the full planned course of olaparib treatment, which is given as adjuvant therapy following initial cancer treatment. It is a national, multicenter, prospective cohort study conducted without altering the usual care provided by doctors. Patients enrolled will be those starting adjuvant olaparib treatment based on their doctor's decision. There are no experimental interventions or treatment changes imposed by the study. The study captures real-world use of olaparib across multiple centers in France. Participants will be followed for at least 18 months after joining the study to see if they complete the full duration of olaparib treatment. Researchers will collect data on treatment adherence and other relevant clinical information during this period. The main outcome measured is the proportion of patients who receive olaparib for the entire planned treatment period.

This research aims to evaluate whether adding a digital telemonitoring platform called "CUREETY TECHCARE" to the usual care can improve outcomes for patients with metastatic triple-negative breast cancer who have not received prior treatment and are starting first-line systemic therapy. The study focuses on whether the telemonitoring platform can improve patients' quality of life, reduce hospitalizations, and increase overall survival compared to standard care alone. Participants in the telemonitoring group will use the Cureety platform weekly to complete questionnaires tailored to their treatment. Responses are analyzed by an algorithm that classifies their health status into risk categories, which guide medical staff in monitoring and managing patient care. The medical team uses a dashboard to track patients daily, respond to alerts, and adjust treatments as needed while providing support during standard care consultations. Patients receive messages with advice based on their condition classification. Throughout the study, patients will have their quality of life measured every three months up to 24 months, and researchers will track hospital-free survival and overall survival from the time of randomization up to 24 months. Patients will need to complete web-based questionnaires and have access to internet-connected devices for telemonitoring. The study will monitor safety and treatment effects during this period to understand the benefits of telemonitoring alongside standard care.