[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Giampaolo Bianchini\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":5},"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":19,"type":20},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.",[24],"HER2-positive Breast Cancer","RECRUITING","2026-04-10",{"date":28,"type":29},"2026-04-15","ACTUAL",{"date":31,"type":29},"2024-12-10",{"date":33,"type":20},"2027-08",{"name":35,"class":36},"Giampaolo Bianchini","OTHER",""]