[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534543":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":33,"responsibleParty":49,"collaborators":51,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":10,"enrollmentInfo":84,"targetDuration":10,"studyType":87,"phases":10,"briefSummary":88,"conditions":89,"keywords":10,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Regina Elena Cancer Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"patients with metastatic triple-negative breast cancer treated with sacituzumab govitecan",null,"The availability of at least one tumor tissue sample to be transferred to the coordinating center will be essential for enrollment in the study. For patients for whom a new sampling is scheduled biopsy of the tumor (primary or metastasis) as per clinical practice, the feasibility of the development will be assessed tumor organoids and the execution of single-cell sequencing on tumor tissue. In these cases, the order of priority in dividing the sampled tissue will be: sufficient quota to carry out the histological examination that will have to be carried out naturally confirm the diagnosis of triple-negative breast cancer. Quota to be prepared as a fresh preparation for the two experiments of feasibility indicated above; quota to be considered as a second sample, to be analyzed at the end of the study.",[13],"Other: data collection",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"data collection","Collection of data relating to the effectiveness of sacituzumab govitecan and evaluation in a real-world context and planned research of predictive biomarkers of efficacy\u002Ftolerability",[9],[20],{"name":21,"affiliation":22,"role":23},"Patrizia Vici, Doctor","IRCCS \"Regina Elena\" National Cancer Institute","PRINCIPAL_INVESTIGATOR",[25,30],{"name":21,"role":26,"phone":27,"phoneExt":28,"email":29},"CONTACT","06-5266.5584","+39","patrizia.vici@ifo.it",{"name":31,"role":26,"phone":10,"phoneExt":10,"email":32},"Eriseld Krasniqi, Doctor","eriseld.krasniqi@ifo.it",[34],{"facility":35,"status":36,"city":37,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"\"Regina Elena\" National Cancer Institute","RECRUITING","Rome","00144","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],12.51133,41.89193,{"lat":45,"lon":44},[48],{"name":21,"role":26,"phone":27,"phoneExt":28,"email":29},{"type":50,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[52,54,56,58,60,62,64,67,69,71,73],{"name":53,"class":6},"Ospedale Sandro Pertini, Roma",{"name":55,"class":6},"Catholic University of the Sacred Heart",{"name":57,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"name":59,"class":6},"Campus Bio-Medico University",{"name":61,"class":6},"Azienda Policlinico Umberto I",{"name":63,"class":6},"San Giovanni Addolorata Hospital",{"name":65,"class":66},"Ospedale \"SS Annunziata\", Chieti","UNKNOWN",{"name":68,"class":66},"Ospedale \"Gaetano Bernabeo\" , Ortona",{"name":70,"class":6},"Hospital San Pietro Fatebenefratelli",{"name":72,"class":66},"presidio Ospedaliero santo spirito in Sassia, Roma",{"name":74,"class":66},"Ospedale di Belcolle - Viterbo","100534543","biomarkers-of-efficacy-and-tolerability-of-sacituzumab-govitecan-in-the-treatment-of-patients-with-triple-negative-breast-cancer-in-the-metastatic-phase-prospective-multicenter-real-world-study-100534543",false,"NCT06240195","Biomarkers of Efficacy and Tolerability of Sacituzumab-Govitecan in the Treatment of Patients With Triple-negative Breast Cancer in the Metastatic Phase: Prospective Multicenter Real-world Study","BIO-PROSA","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Histological diagnosis of TNBC;\n* Locally advanced unresectable or metastatic disease;\n* Indication for treatment with SG in monotherapy according to clinical practice (patients pre-treated with at least two lines of systemic therapy, of which at least one in an advanced stage);\n* Availability of at least one tumor tissue sample (from primary tumor or metastasis) to be sent to the coordinating center (IRE);\n* Written informed consent;\n* Availability to comply with the procedures established by the protocol, according to the methods and times described.\n\nExclusion Criteria:\n\n* Patients with a history of other malignancies;\n* Contraindications to the use of sacituzumab govitecan SG;\n* Untreated and\u002For clinically unstable (symptomatic) brain metastases.","FEMALE","18 Years",{"count":85,"type":86},60,"ESTIMATED","OBSERVATIONAL","Observational, prospective, multicenter study. Collection of data relating to the effectiveness of sacituzumab govitecan SG, in a real-world context and planned research of predictive biomarkers of efficacy\u002Ftolerability carried out on multiple platforms at the center coordinator.",[90],"Breast Cancer","2026-06-04",{"date":93,"type":94},"2026-06-05","ACTUAL",{"date":96,"type":94},"2023-01-17",{"date":98,"type":86},"2027-06-17",{"name":5,"class":6},1]