[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100333263":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":18,"centralContacts":18,"locations":19,"responsibleParty":74,"collaborators":18,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":18,"enrollmentInfo":85,"targetDuration":18,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":97,"whyStopped":98,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Institut Claudius Regaud","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Patients with metastatic breast cancer","Patients with metastatic breast cancer treated with trastuzumab + pertuzumab + taxane in the metastatic first line.",[12],"Other: 2 FES-PET Imaging will be performed:",[14],{"type":6,"name":15,"description":16,"armGroupLabels":17,"otherNames":18},"2 FES-PET Imaging will be performed:","* before treatment initiation\n* before treatment cycle 3 initiation",[9],null,[20,32,41,50,59,68],{"facility":21,"status":18,"city":22,"state":18,"zip":23,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":18},"Clinique Claude Bernard","Albi","81000","France","FR",{"type":27,"coordinates":28},"Point",[29,30],2.148,43.9298,{"lat":30,"lon":29},{"facility":33,"status":18,"city":34,"state":18,"zip":35,"country":24,"countryCode":25,"cosmosGeoPoint":36,"geoPoint":40,"contacts":18},"Centre Hospitalier Auch","Auch","32008",{"type":27,"coordinates":37},[38,39],0.58856,43.64561,{"lat":39,"lon":38},{"facility":42,"status":18,"city":43,"state":18,"zip":44,"country":24,"countryCode":25,"cosmosGeoPoint":45,"geoPoint":49,"contacts":18},"Clinique Capio La Croix Du Sud","Quint-Fonsegrives","31130",{"type":27,"coordinates":46},[47,48],1.5272,43.5852,{"lat":48,"lon":47},{"facility":51,"status":18,"city":52,"state":18,"zip":53,"country":24,"countryCode":25,"cosmosGeoPoint":54,"geoPoint":58,"contacts":18},"Centre Hospitalier de Rodez","Rodez","12000",{"type":27,"coordinates":55},[56,57],2.57338,44.35258,{"lat":57,"lon":56},{"facility":60,"status":18,"city":61,"state":18,"zip":62,"country":24,"countryCode":25,"cosmosGeoPoint":63,"geoPoint":67,"contacts":18},"IUCT-O","Toulouse","31059",{"type":27,"coordinates":64},[65,66],1.44367,43.60426,{"lat":66,"lon":65},{"facility":69,"status":18,"city":61,"state":18,"zip":70,"country":24,"countryCode":25,"cosmosGeoPoint":71,"geoPoint":73,"contacts":18},"Clinique Pasteur","31076",{"type":27,"coordinates":72},[65,66],{"lat":66,"lon":65},{"type":75,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100333263","the-use-of-fes-pet-imaging-as-a-tool-to-detect-a-possible-reversion-of-estrogen-receptor-er--status-in-patients-with-metastatic-breast-cancer-her2--and-er-neg-treated-with-trastuzumab--pertuzumab--taxane-100333263",false,"NCT03619044","The Use of FES-PET Imaging as a Tool to Detect a Possible Reversion of Estrogen Receptor (ER)-α Status in Patients With Metastatic Breast Cancer HER2 + and ERα Neg Treated With Trastuzumab + Pertuzumab + Taxane.","REVER","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patient with metastatic breast cancer HER2 + (IHC+++ and\u002For HER2 amplification in ISH according to ASCO recommendations), ERα neg (0% in IHC) and Progesterone Receptor neg (0% in IHC).\n3. Patient eligible according to the investigator for a treatment with trastuzumab + pertuzumab + taxane in the metastatic first line.\n4. Available biopsy of a tumor lesion (archived material) or biopsiable tumor lesion for study (primitive tumor or metastasis other than bone).\n5. OMS ≤ 2.\n6. For non-menopausal patients, use of an effective contraceptive method at entry into the study and for the duration of the study.\n7. Patient affiliated to a Social Health Insurance in France.\n8. Patient must provide written informed consent prior to any study specific procedures.\n\nExclusion Criteria:\n\n1. Any previous treatment for metastatic disease.\n2. Prior adjuvant treatment with anti-HER2 antibodies taken within 6 months.\n3. Patient with isolated hepatic metastasis.\n4. Patient with hemostasis disorders.\n5. Unbalanced Diabetes.\n6. Patient with usual formal contraindication to PET\u002FTDM Imaging.\n7. Patient who has already started trastuzumab + pertuzumab + taxane treatment.\n8. Pregnant or breastfeeding women.\n9. Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and\u002For compliance to study procedure.\n10. Patient protected by law.","FEMALE","18 Years",{"count":86,"type":87},4,"ACTUAL","INTERVENTIONAL",[90],"NA","This is an exploratory, prospective and multicentric study aiming to highlight by FES-PET imaging that an anti-HER2 treatment by trastuzumab + pertuzumab can reverse the ERα status in patients with metastatic breast cancer HER2 + and ERα neg.\n\nFor each included patient, 2 FES-PET Imaging will be performed for the study (before cancer treatment initiation and before the cycle 3 of treatment) at the IUCT-O center (Institut Universitaire du Cancer de Toulouse).\n\nTreatment (trastuzumab + pertuzumab + taxane) will be administered according to the current recommendations in each participant center.\n\nPatients will be followed during the 3 cycles of treatment.",[93],"HER2-positive Breast Cancer",[95,96,93],"Metastatic breast cancer","FES-PET","TERMINATED","Slow recruitment rate","2022-01-27",{"date":101,"type":87},"2022-02-10",{"date":103,"type":87},"2020-08-28",{"date":105,"type":87},"2021-07-09",{"name":5,"class":6},6]