[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"antineoplastic-combined-chemotherapy-protocols\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:antineoplastic-combined-chemotherapy-protocols":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100628883","folfirinox-induction-chemotherapy-for-synchronous-liver-metastases-100628883",false,"NCT07467434","FOLFIRINOX Induction Chemotherapy for Synchronous Liver Metastases","Multicenter Cohort Study of Mid\u002FLower Rectal Cancer With Resectable Synchronous Liver Metastases Treated With FOLFIRINOX Induction Chemotherapy","SYNCHRONOX","Inclusion Criteria:\n\n* Adult subjects aged 18 years and older\n* Adenocarcinoma of the middle and\u002For lower rectum pMMR T3, T4, and\u002For N+\n* Resectable synchronous liver metastases\n\nExclusion Criteria:\n\n* Minor under the age of 18.\n* Presence of extrahepatic metastases\n* Induction chemotherapy with FOLFIRINOX of less than 2 courses","ALL","18 Years",{"count":20,"type":21},550,"ESTIMATED","OBSERVATIONAL","SYNCHRONOX is a multicenter cohort (retrospective then prospective) intending to include 550 patients with mid or low rectal adenocarcinoma (pMMR, T3-T4 and\u002For N+) and resectable synchronous liver metastases, treated upfront with at least two cycles of induction FOLFIRINOX chemotherapy. The primary objective is to determine, at 18 months, the R0 resection rate of both tumor sites (rectum and liver), while secondary objectives focus on 3 year overall and progression free survival, radiological and pathological responses, postoperative morbidity and mortality, and comparison of the different surgical strategies after FOLFIRINOX.",[25,26,27,28],"Rectal Cancer","Synchronous Liver Metastases","Antineoplastic Combined Chemotherapy Protocols","Surgical Therapy",[30,31],"Prospective observational multicentric cohort","Retrospective observational multicentric cohort","RECRUITING","2026-06-05",{"date":35,"type":36},"2026-06-09","ACTUAL",{"date":38,"type":36},"2026-05-01",{"date":40,"type":21},"2034-05-01",{"name":42,"class":43},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":44},"100563845","retrospective-observational-study-of-the-safety-and-toxicity-management-of-abemaciclib-in-combination-with-adjuvant-hormone-therapy-in-patients-with-rh-her2-nonoveramplified-breast-cancer-real-life-data-monarche29-100563845","NCT06621459","Retrospective Observational Study of the Safety and Toxicity Management of Abemaciclib in Combination with Adjuvant Hormone Therapy in Patients with RH+ ,HER2-nonoveramplified Breast Cancer, Real-life Data (MONARCHE29)","Retrospective Observational Study of the Safety and Toxicity Management of Abemaciclib in Combination with Adjuvant Hormone Therapy in Patients with RH+ ,HER2-nonoveramplified Breast Cancer, Real-life Data","MONARCHE29","Inclusion Criteria:\n\n* Adult patient\n* Patient who has received adjuvant ABEMACICLIB in combination with hormone therapy\n* Patient with localized RH+ HER2 non-amplified breast cancer and eligible for treatment with ABEMACICLIB according to the recommendations of the MA (Marketing Authorization) as defined below:\n\n  * 4 ipsilateral positive axillary lymph nodes OR\n\n    1. to 3 ipsilateral positive axillary lymph node(s) with at least one of the following two criteria: histological grade 3 or primary tumor size ≥5 cm\n\nExclusion Criteria:\n\n* Patients under legal protection (guardianship, trusteeship, etc.)\n* Refusal to participate",{"count":54,"type":21},30,"Overall survival at 8 years under treatment for localized hormone-dependent breast cancer is 93.3% (1). Adjuvant therapy, especially hormone therapy, helps reduce the risk of recurrence.\n\nHowever, the risk of relapse remains significant, estimated at around 20% according to studies. The SOFT study, which compares the type of hormone therapy used in premenopausal patients, estimates a relapse risk of 21.1% at 8 years (1), especially when there is initial lymph node involvement. In fact, in cases of lymph node involvement, the cumulative relapse rate at 10 years after stopping hormone therapy ranges between 19% and 36% (2), and the risk of death from breast cancer 20 years after stopping hormone therapy is estimated at 28% to 49% (2).\n\nCDK4\u002F6 inhibitors first demonstrated their efficacy at the metastatic stage. Abemaciclib improved median survival to 46.7 months compared to a median of 37.3 months with hormone therapy alone (Monarch 2 (3) and Monarch 3 (4)). Palbociclib showed in PALOMA-2 (5) an improvement in progression-free survival (24.8 months versus 14.5 months) without an improvement in overall survival. Ribociclib, in turn, demonstrated in MONALEESA 2 (6) an improvement in PFS (25.3 months versus 16 months) and in overall survival (63.9 months versus 51.4 months). These treatments have become the standard first-line treatment for patients with RH+ HER2 non-amplified breast cancer.\n\nGiven the results in advanced lines, CDK4\u002F6 inhibitors have been the subject of studies in localized breast cancer, particularly in this high-risk population where the recurrence rate remains significant.\n\nThe MONARCH-E study, published on September 20, 2020 (7), led to the approval of Abemaciclib by European authorities at the time of the initial publication (median follow-up of 15.4 months) and to reimbursement starting in May 2023 after a second interim analysis (8) in this at-risk population, with a 5.6% reduction in relapse risk after 42 months of follow-up compared to hormone therapy alone.\n\nIt is crucial to clearly define the at-risk population in order to offer them treatment intensification while maintaining a satisfactory quality of life. The group benefiting from Abemaciclib presented grade III toxicity in 43% of cases and grade IV toxicity in 2.5%.\n\nReal-world data are needed to better understand the management and toxicity of this treatment.",[57,58,59,27,60],"Brest Cancer","Abemaciclib","Adjuvant Therapy","Breast Neoplasms",[58,59,27,62,63,64],"Breast Cancer","Real-life","Real Word Data","2024-09-27",{"date":67,"type":36},"2024-10-01",{"date":69,"type":21},"2024-09-26",{"date":71,"type":21},"2025-10-31",{"name":73,"class":43},"University Hospital, Brest"]