[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555922":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":19,"responsibleParty":38,"collaborators":7,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":7,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":7,"enrollmentInfo":51,"targetDuration":7,"studyType":54,"phases":7,"briefSummary":55,"conditions":56,"keywords":7,"overallStatus":22,"whyStopped":7,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},{"fullName":5,"class":6},"IRCCS Ospedale San Raffaele","OTHER",null,[9],{"name":10,"affiliation":11,"role":12},"Giampaolo Bianchini, MD","Head Breast Cancer Group - Department of Medical Oncology - IRCCS San Raffaele Hospital","PRINCIPAL_INVESTIGATOR",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Tiziana Daniele, PhD","CONTACT","+39 02 2643 6381","daniele.tiziana@hsr.it",[20],{"facility":21,"status":22,"city":23,"state":24,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"IRCCS San Raffaele Hospital","RECRUITING","Milan","Lombardy","20132","Italy","IT",{"type":29,"coordinates":30},"Point",[31,32],9.18951,45.46427,{"lat":32,"lon":31},[35],{"name":10,"role":16,"phone":36,"phoneExt":7,"email":37},"+39 02 2643 6530","bianchini.giampaolo@hsr.it",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"SPONSOR_INVESTIGATOR","Giampaolo Bianchini","Head of Breast Cancer Group, Department of Medical Oncology -PI-","100555922","tumor-microenvironment-spatial-interaction-to-identify-markers-of-resistance-to-therapy-in-her2-breast-cancer-patients-100555922",false,"NCT06518382","Tumor-microenvironment Spatial Interaction to Identify Markers of Resistance to Therapy in HER2+ Breast Cancer Patients","A Retrospective Observational Study Characterizing Tumour-microenvironment Spatial Interaction Aimed at the Identification of New Markers of Resistance to Therapy in HER2-positive Breast Cancer Patients","Inclusion Criteria:\n\n1. Participant is willing and able to give informed consent for participation in the study.\n2. Patient underwent the following procedure before surgery: biopsy, sequential chemotherapy comprising treatment with antracyclines (AC\u002FEC q21, 4 cycles) followed by taxanes (paclitaxel 1,8,15 q21 for 12 weeks) in combination with the anti-HER2 antibody trastuzumab.\n3. Specimen collected at surgery display residual invasive disease in the breast\u002Flymph node.\n\nExclusion Criteria:\n\n1. pre-existing conditions or concurrent diagnoses;\n2. concomitant use of other medications during neo-adjuvant treatment;\n3. quality of stored specimen does not meet the standard for Imaging Mass Cytometry analysis.","FEMALE","18 Years",{"count":52,"type":53},10,"ESTIMATED","OBSERVATIONAL","This retrospective observational study aims at the comparison of the tumour-microenvironment tissue architecture before and after neo-adjuvant therapy in samples from HER2-positive (HER2+) breast cancer (BrCa) patients that display residual invasive disease in the breast\u002Flymph node at surgery after standard-of-care combined chemotherapy and trastuzumab treatment.\n\nThe working hypothesis of the investigators is that:\n\nTherapy imposes a selective pressure on tumour-microenvironment features promoting resistance to treatment.\n\nParticipant that have already undergone neo-adjuvant treatment as part of their regular medical care for HER2-positive breast cancer will provide access to formalin-fixed paraffin-embedded (FFPE) samples taken before and after therapy.\n\nTumoral, peri-tumoral and stromal regions of each specimen will be analyzed with the ultimate goal to identify new biomarkers (and putative targets) of resistance to therapy.",[57],"HER2-positive Breast Cancer","2026-04-10",{"date":60,"type":61},"2026-04-15","ACTUAL",{"date":63,"type":61},"2024-12-10",{"date":65,"type":53},"2027-08",{"name":40,"class":6},1]