[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531124":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":43,"centralContacts":47,"locations":58,"responsibleParty":326,"collaborators":328,"id":332,"slug":333,"hasResults":334,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":334,"sex":340,"minAge":341,"maxAge":52,"enrollmentInfo":342,"targetDuration":52,"studyType":345,"phases":346,"briefSummary":348,"conditions":349,"keywords":351,"overallStatus":101,"whyStopped":52,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":364},{"fullName":5,"class":6},"Institut Curie","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: Endocrine therapy","SHAM_COMPARATOR","1. Patients in whom all tumor sites display a FES SUVmax ≥2 AND who have low levels of circulating tumor biomarkers will be treated with endocrine therapy.\n2. Patients in whom 18F-FES PET shows an heterogenous uptake, with one or maximum two tumor sites with low FES uptake (SUVmax \\\u003C2) that represent less than 20% of all tumor sites and are deemed accessible to local treatment (e.g. stereotactic radiation therapy or another equivalent local therapy) will be treated, if they have low levels of circulating tumor biomarkers, by 2nd line endocrine therapy in Arm A, combined with the local treatment of FES-negative lesions.",[13,14],"Combination Product: Endocrine therapy","Combination Product: Endocrine therapy combined with the local treatment of FES-negative lesions",{"label":16,"type":17,"description":18,"interventionNames":19},"Arm B: Chemotherapy","ACTIVE_COMPARATOR","All other patients, i.e. (i) patients in whom most or ≥3 lesions display a FES SUVmax \\\u003C2 that are not amenable to local treatment, (ii) patients with high levels of circulating tumor biomarkers, will be randomized between chemotherapy in Arm B and endocrine therapy in Arm C.",[13,20],"Combination Product: Chemotherapy",{"label":22,"type":17,"description":18,"interventionNames":23},"Arm C: Endocrine therapy",[13,20],[25,32,37],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"COMBINATION_PRODUCT","Endocrine therapy","Consist in single agent endocrine therapy or in combination with targeted therapy, per guidelines and label. LH-RH agonist will be used in combination with endocrine therapy whenever appropriate and per label.",[9,16,22],[31],"Standardized endocrine therapy regimen",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Endocrine therapy combined with the local treatment of FES-negative lesions","Consist in single agent endocrine therapy or in combination with targeted therapy, per guidelines and label. LH-RH agonist will be used in combination with endocrine therapy whenever appropriate and per label. Cases with only 1 or 2 FES-negative lesions that are accessible to local treatment will be reviewed by the Centralized Reading Committee (including a radiation oncologist) to confirm the feasibility of local treatment.",[9],[31],{"type":26,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Chemotherapy","Consist in single agent chemotherapy, poly-chemotherapy, or antibody-drug conjugates, per guidelines and label. Patients who are eligible (per drug label) may receive PARP inhibitor if allocated to Arm B.",[16,22],[42],"Standardized chemotherapy regimen",[44],{"name":45,"affiliation":5,"role":46},"Steven Le GOUILL, PhD","STUDY_DIRECTOR",[48,54],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},"François-Clément BIDARD, PhD","CONTACT","+33147111515",null,"francois-clement.bidard@curie.fr",{"name":55,"role":50,"phone":56,"phoneExt":52,"email":57},"Isabelle TURBIEZ","+33156245630","drci.promotion@curie.fr",[59,76,89,99,113,126,139,152,165,178,191,204,217,229,242,255,265,275,287,300,313],{"facility":60,"status":61,"city":62,"state":52,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Centre Hospitalier de la Côte basque","NOT_YET_RECRUITING","Bayonne","64100","France","FR",{"type":67,"coordinates":68},"Point",[69,70],-1.473,43.49316,{"lat":70,"lon":69},[73],{"name":74,"role":50,"phone":52,"phoneExt":52,"email":75},"Thomas GRELLETY, MD","tgrellety@ch-cotebasque.fr",{"facility":77,"status":61,"city":78,"state":52,"zip":79,"country":64,"countryCode":65,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Institut Bergonié","Bordeaux","33076",{"type":67,"coordinates":81},[82,83],-0.58046,44.84124,{"lat":83,"lon":82},[86],{"name":87,"role":50,"phone":52,"phoneExt":52,"email":88},"Maxime Brunet, MD","m.brunet@bordeaux.unicancer.fr",{"facility":90,"status":61,"city":78,"state":52,"zip":91,"country":64,"countryCode":65,"cosmosGeoPoint":92,"geoPoint":94,"contacts":95},"Polyclinique Bordeaux Nord Aquitaine","33077",{"type":67,"coordinates":93},[82,83],{"lat":83,"lon":82},[96],{"name":97,"role":50,"phone":52,"phoneExt":52,"email":98},"Laura POETSCH, MD","lpoetsch@gor.bordeauxnord.com",{"facility":100,"status":101,"city":102,"state":52,"zip":103,"country":64,"countryCode":65,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Centre Francois Baclesse","RECRUITING","Caen","14076",{"type":67,"coordinates":105},[106,107],-0.35912,49.18585,{"lat":107,"lon":106},[110],{"name":111,"role":50,"phone":52,"phoneExt":52,"email":112},"George EMILE","g.emile@baclesse.unicancer.fr",{"facility":114,"status":101,"city":115,"state":52,"zip":116,"country":64,"countryCode":65,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Centre Georges Francois Leclerc","Dijon","21079",{"type":67,"coordinates":118},[119,120],5.01391,47.31344,{"lat":120,"lon":119},[123],{"name":124,"role":50,"phone":52,"phoneExt":52,"email":125},"Sylvain LADOIRE, MD","sladoire@cgfl.fr",{"facility":127,"status":101,"city":128,"state":52,"zip":129,"country":64,"countryCode":65,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Centre Oscar Lambret","Lille","59000",{"type":67,"coordinates":131},[132,133],3.05512,50.63391,{"lat":133,"lon":132},[136],{"name":137,"role":50,"phone":52,"phoneExt":52,"email":138},"Nawale HAJJAJI, MD","n-hajjaji@o-lambret.fr",{"facility":140,"status":61,"city":141,"state":52,"zip":142,"country":64,"countryCode":65,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"CHU Limoges","Limoges","87000",{"type":67,"coordinates":144},[145,146],1.24759,45.83362,{"lat":146,"lon":145},[149],{"name":150,"role":50,"phone":52,"phoneExt":52,"email":151},"Elise DELUCHE, MD","Elise.deluche@chu-limoges.fr",{"facility":153,"status":61,"city":154,"state":52,"zip":155,"country":64,"countryCode":65,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Centre Leon Bérard","Lyon","69008",{"type":67,"coordinates":157},[158,159],4.84789,45.74906,{"lat":159,"lon":158},[162],{"name":163,"role":50,"phone":52,"phoneExt":52,"email":164},"Sandrine PARISSE-DI MARTINO, MD","sandrine.parisse-dimartino@lyon.unicancer.fr",{"facility":166,"status":101,"city":167,"state":52,"zip":168,"country":64,"countryCode":65,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Institut Paoli-Calmettes","Marseille","13009",{"type":67,"coordinates":170},[171,172],5.38107,43.29695,{"lat":172,"lon":171},[175],{"name":176,"role":50,"phone":52,"phoneExt":52,"email":177},"Alexandre TASSIN DE NONNEVILLE, MD","tassindenonnevillea@ipc.unicancer.fr",{"facility":179,"status":101,"city":180,"state":52,"zip":181,"country":64,"countryCode":65,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Institut du Cancer Montpellier","Montpellier","34298",{"type":67,"coordinates":183},[184,185],3.87635,43.61093,{"lat":185,"lon":184},[188],{"name":189,"role":50,"phone":52,"phoneExt":52,"email":190},"Marie ALEXANDRE, MD","Marie.Alexandre@icm.unicancer.fr",{"facility":192,"status":101,"city":193,"state":52,"zip":194,"country":64,"countryCode":65,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Centre Antoine lacassagne","Nice","06189",{"type":67,"coordinates":196},[197,198],7.26608,43.70313,{"lat":198,"lon":197},[201],{"name":202,"role":50,"phone":52,"phoneExt":52,"email":203},"Olivier Humbert, MD","Olivier.humbert@nice.unicancer.fr",{"facility":205,"status":61,"city":206,"state":52,"zip":207,"country":64,"countryCode":65,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Hôpital Universitaire de Nimes","Nîmes","30029",{"type":67,"coordinates":209},[210,211],4.35788,43.83665,{"lat":211,"lon":210},[214],{"name":215,"role":50,"phone":52,"phoneExt":52,"email":216},"Frédéric FITENI, MD","frederic.fiteni@chu-nimes.fr",{"facility":5,"status":101,"city":218,"state":52,"zip":219,"country":64,"countryCode":65,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"Paris","75005",{"type":67,"coordinates":221},[222,223],2.3488,48.85341,{"lat":223,"lon":222},[226],{"name":227,"role":50,"phone":52,"phoneExt":52,"email":228},"Audrey BELLESOEUR, MD","audrey-bellesoeur@curie.fr",{"facility":230,"status":101,"city":231,"state":52,"zip":232,"country":64,"countryCode":65,"cosmosGeoPoint":233,"geoPoint":237,"contacts":238},"Centre Eugène Marquis","Rennes","35042",{"type":67,"coordinates":234},[235,236],-1.67431,48.11109,{"lat":236,"lon":235},[239],{"name":240,"role":50,"phone":52,"phoneExt":52,"email":241},"Antoine DELEUZE, MD","a.deleuze@rennes.unicancer.fr",{"facility":243,"status":61,"city":244,"state":52,"zip":245,"country":64,"countryCode":65,"cosmosGeoPoint":246,"geoPoint":250,"contacts":251},"Centre Henri Becquerel","Rouen","76038",{"type":67,"coordinates":247},[248,249],1.09932,49.44313,{"lat":249,"lon":248},[252],{"name":253,"role":50,"phone":52,"phoneExt":52,"email":254},"Florian CLATOT, MD","florian.clatot@chb.unicancer.fr",{"facility":5,"status":101,"city":256,"state":52,"zip":257,"country":64,"countryCode":65,"cosmosGeoPoint":258,"geoPoint":262,"contacts":263},"Saint-Cloud","92210",{"type":67,"coordinates":259},[260,261],2.20289,48.84598,{"lat":261,"lon":260},[264],{"name":49,"role":50,"phone":52,"phoneExt":52,"email":53},{"facility":266,"status":267,"city":268,"state":52,"zip":269,"country":64,"countryCode":65,"cosmosGeoPoint":270,"geoPoint":274,"contacts":52},"Bruno MAUCHERAT","WITHDRAWN","Saint-Herblain","44805",{"type":67,"coordinates":271},[272,273],-1.651,47.21154,{"lat":273,"lon":272},{"facility":276,"status":61,"city":277,"state":52,"zip":52,"country":64,"countryCode":65,"cosmosGeoPoint":278,"geoPoint":282,"contacts":283},"Centre de lutte contre le cancer Paul Strauss","Strasbourg",{"type":67,"coordinates":279},[280,281],7.74553,48.58392,{"lat":281,"lon":280},[284],{"name":285,"role":50,"phone":52,"phoneExt":52,"email":286},"Thierry PETIT, MD","t.petit@icans.eu",{"facility":288,"status":61,"city":289,"state":52,"zip":290,"country":64,"countryCode":65,"cosmosGeoPoint":291,"geoPoint":295,"contacts":296},"Oncopole Claudius Regaud","Toulouse","31059",{"type":67,"coordinates":292},[293,294],1.44367,43.60426,{"lat":294,"lon":293},[297],{"name":298,"role":50,"phone":52,"phoneExt":52,"email":299},"Florence DALENC, MD","Dalenc.florence@iuct-oncopole.fr",{"facility":301,"status":61,"city":302,"state":52,"zip":303,"country":64,"countryCode":65,"cosmosGeoPoint":304,"geoPoint":308,"contacts":309},"Hôpital Bretonneau-CHU Tours","Tours","37044",{"type":67,"coordinates":305},[306,307],0.70398,47.39484,{"lat":307,"lon":306},[310],{"name":311,"role":50,"phone":52,"phoneExt":52,"email":312},"Hélène VEGAS, MD","h.vegas@chu-tours.fr",{"facility":314,"status":101,"city":315,"state":52,"zip":316,"country":64,"countryCode":65,"cosmosGeoPoint":317,"geoPoint":321,"contacts":322},"Institut de Cancerologie de Lorraine","Vandœuvre-lès-Nancy","54519",{"type":67,"coordinates":318},[319,320],6.17114,48.66115,{"lat":320,"lon":319},[323],{"name":324,"role":50,"phone":52,"phoneExt":52,"email":325},"Vincent Massard, MD","v.massard@nancy.unicancer.fr",{"type":327,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR",[329],{"name":330,"class":331},"Zionexa","INDUSTRY","100531124","phase-3-eclectic-estrotep-and-circulating-biomarkers-for-er-positive-her2-negative-metastatic-breast-cancer-patients-100531124",false,"NCT06195709","ECLECTIC: EstroTEP and Circulating Biomarkers for ER-positive HER2-negative Metastatic Breast Cancer Patients","ECLECTIC: EstroTEP and Circulating Biomarkers to Determine the Optimal Second Line Therapy for ER-positive HER2-negative Metastatic Breast Cancer Patients","ECLECTIC","Inclusion Criteria:\n\n1. Metastatic invasive breast carcinoma of no special type.\n2. Females and males of age ≥18 years.\n3. Life expectancy \\> 3 months.\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.\n5. Estrogen Receptor (ER)-positive (≥10%) and HER2-negative (ASCO\u002FCollege of American Pathologists guidelines) breast cancer, per local assessment on the most recent breast cancer tissue examined.\n6. Tumor block Formalin-Fixed Paraffin-Embedded (primary tumor or metastasis) available.\n7. Patients whose disease has progressed on first line endocrine therapy with aromatase inhibitor and CDK4\u002F6 inhibitor and who are deemed eligible, per investigator assessment, to a second line endocrine therapy. The progression on first line endocrine therapy with aromatase inhibitor and CDK4\u002F6 inhibitor must have occurred after more than 6 months on treatment.\n8. Patients with available 18F-FDG PET\u002FCT imaging\n9. Evaluable disease per RECIST criteria and measurable disease per PERCIST criteria.\n10. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and any protocol-related procedures including screening evaluations.\n11. Signed informed consent.\n12. Patient affiliated to a social security system.\n\nExclusion criteria:\n\n1. Other breast cancer subtype (e.g. invasive lobular breast carcinoma).\n2. One or more prior line of chemotherapy in the metastatic setting.\n3. Any other systemic treatment given at metastatic disease than the first line therapy with aromatase inhibitor and CDK4\u002F6 inhibitor.\n4. Visceral crisis, per investigator's assessment.\n5. Liver-only metastases.\n6. Prior exposure to any authorized or experimental agent degrading the estrogen receptor (fulvestrant, oral SERDs, PROTAC, etc).\n7. Pregnancy or lactation period.\n8. In women of childbearing potential or premenopausal women or women with amenorrhea of less than 12 months, without adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization; LH-RH agonist cannot be considered as an efficient contraceptive measure), positive urinary or serum pregnancy test 72 hours before 18F-FES PET\u002FCT.\n9. Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease. Patients with a history of CNS metastases or cord compression are eligible if they have been treated with local therapy (e.g., radiotherapy, stereotactic surgery) and are clinically stable and off anticonvulsants and steroids for at least 4 weeks before treatment start.\n10. History of previous cancer or hematological malignancy within 3 years preceding patient enrollment in the trial. Multiple primary breast cancers (controlateral\u002Fipsilateral cancers\u002Flocal relapses) are allowed pending all tumors were ER+ HER2-.\n11. Persons deprived of their freedom or under guardianship or incapable of giving consent.","ALL","18 Years",{"count":343,"type":344},300,"ESTIMATED","INTERVENTIONAL",[347],"PHASE3","Eclectic is a strategy trial; once the class of treatment (endocrine therapy or chemotherapy) has been allocated according to 16α-18F-fluoro-17β-oestradiol (18F-FES) Positron Emission Tomography\u002FComputed Tomography (PET\u002FCT) results and circulating tumor biomarkers, clinicians will decide which treatment to use.",[350],"Breast Carcinoma",[352,353,354],"Metastatic","PET\u002FCT 18F-FES","Circulating markers","2026-04-16",{"date":357,"type":358},"2026-04-17","ACTUAL",{"date":360,"type":358},"2024-05-27",{"date":362,"type":344},"2030-09-27",{"name":5,"class":6},21]