[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640044":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":29,"studyPopulation":22,"armGroups":30,"interventions":37,"overallOfficials":40,"centralContacts":44,"locations":53,"responsibleParty":67,"collaborators":22,"id":69,"slug":22,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":22,"enrollmentInfo":78,"targetDuration":22,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":92,"whyStopped":22,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Centre Henri Becquerel","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Concordance rate between the response estimated by [68Ga]Ga-NOTA-anti-HER2-sdAb PET\u002FCT and the invasive pathological complete response","The concordance rate is defined as the proportion of patients correctly classified by the post-therapeutic PET\u002FCT compared to the gold standard histopathological assessment (ypT0\u002Fis ypN0).","2 weeks after surgery",[14,18],{"measure":15,"description":16,"timeFrame":17},"Concordance rate between the response estimated by [68Ga]Ga-NOTA-anti-HER2-sdAb PET\u002FCT and the pCR on both invasive and non-invasive components","The concordance rate is calculated as the proportion of correctly classified patients compared to the non-invasive pCR definition (ypT0 ypN0), in addition to the invasive definition (ypT0\u002Fis ypN0)","two weeks after surgery",{"measure":19,"description":20,"timeFrame":21},"Comparison of the diagnostic performance of [68Ga]Ga-NOTA-anti-HER2-sdAb PET\u002FCT against other conventional imaging modalities in predicting the invasive pCR","ΔSUV is defined as the relative change in SUVmax between the baseline and post-therapeutic \\[68Ga\\]Ga-NOTA-anti-HER2-sdAb PET\u002FCT, compared according to invasive pathological complete response (ypT0\u002Fis ypN0).","Two weeks after surgery",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":28,"maskingDescription":22,"whoMasked":22},"NONE","In early-stage HER2-positive breast cancer, neoadjuvant chemotherapy is frequently required, and pathological complete response (pCR) correlates with excellent prognosis. However, no non-invasive imaging method reliably predicts pCR, making surgery mandatory despite its aesthetic, functional, and psychological burden. Recently, new functional imaging tracers targeting the HER2 protein have been developed. Among these, \\[68Ga\\]Ga-NOTA-anti-HER2-sdAb is of particular interest due to its molecular characteristic; it has demonstrated favorable safety profile and ability to identify HER2+ cells in vivo. This trial evaluates its ability to predict pCR, with the prospect of paving the way for future therapeutic de escalation and surgical sparing.",[31],{"label":32,"type":33,"description":34,"interventionNames":35},"[68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography","EXPERIMENTAL","Patients will undergo an \\[68Ga\\]Ga-NOTA-anti-HER2-sdAb PET\u002FCT before neoadjuvant chemotherapy and 15 days prior the scheduled surgery",[36],"Other: [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography",[38],{"type":6,"name":32,"description":34,"armGroupLabels":39,"otherNames":22},[32],[41],{"name":42,"affiliation":5,"role":43},"Florian Clatot, MD, PhD","PRINCIPAL_INVESTIGATOR",[45,49],{"name":42,"role":46,"phone":47,"phoneExt":22,"email":48},"CONTACT","+33232082981","florian.clatot@chb.uncancer.fr",{"name":50,"role":46,"phone":51,"phoneExt":22,"email":52},"Doriane Richard, PhD","+33232082985","doriane.richard@chb.unicancer.fr",[54],{"facility":5,"status":22,"city":55,"state":22,"zip":22,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Rouen","France","FR",{"type":59,"coordinates":60},"Point",[61,62],1.09932,49.44313,{"lat":62,"lon":61},[65],{"name":42,"role":46,"phone":47,"phoneExt":22,"email":66},"florian.clatot@chb.unicancer.fr",{"type":68,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100640044",false,"NCT07593976","Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET\u002FCT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer","Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET\u002FCT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer (GATHER): a Study Protocol for a Monocentric, Prospective, Interventional, Phase 2, Imaging Biomarker Trial.","GATHER","Inclusion Criteria:\n\n* Female aged 18 years or older\n* Histologically proven HER2-positive early breast cancer, defined as IHC 3+ or IHC 2+ with ISH amplification\n* Indication for neoadjuvant chemotherapy combined with anti-HER2 targeted therapy followed by surgery, as determined by a multidisciplinary tumor board\n* ECOG performance status of 0 or 1\n* Affiliated to or beneficiary of a social protection scheme\n* Written informed consent signed prior to any study-specific procedure\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n\n  * Patient not treated with curative intent\n  * History of ipsilateral breast cancer treated by surgery and\u002For radiotherapy\n  * Lobular histology\n  * Known contraindication or hypersensitivity to \\[68Ga\\]Ga-NOTA-anti-HER2-sdAb or any of its radiopharmaceutical excipients\n  * Known contraindication or hypersensitivity to \\[18F\\]F-FDG or any of its radiopharmaceutical excipients\n  * Concurrent enrollment in another clinical trial evaluating radiopharmaceuticals\n  * Patient under guardianship, curatorship, or judicial protection\n  * Patient deprived of liberty\n  * Inability to understand the study or comply with trial constraints due to linguistic, psychological, or geographical barriers","FEMALE","18 Years",{"count":79,"type":80},42,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","The GATHER trial aim to evaluate the diagnostic performance of \\[68Ga\\]Ga-NOTA-anti-HER2-sdAb PET\u002FCT in predicting pCR following neoadjuvant chemotherapy. This study is part of the development of new functional, non-invasive approaches with the aim of offering personalized therapeutic approaches.",[86],"Breast Cancer",[88,89,90,91],"early breast cancer","Positron emission tomography","Gallium radioisotopes","pathological complete response","NOT_YET_RECRUITING","2026-05-12",{"date":95,"type":96},"2026-05-18","ACTUAL",{"date":98,"type":80},"2026-09-01",{"date":100,"type":80},"2028-03-01",{"name":5,"class":6},1]