[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639117":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":49,"centralContacts":54,"locations":64,"responsibleParty":84,"collaborators":10,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":10,"enrollmentInfo":98,"targetDuration":10,"studyType":101,"phases":10,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":67,"whyStopped":10,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Istituto Oncologico Veneto IRCCS","OTHER",[8,17,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Triple-negative ILC",null,"ER \\\u003C1%, PR \\\u003C1% and HER2-negative (IHC 0, 1+, or 2+ with negative ISH). Within this cohort, HER2 expression will be further categorized, where assessable, as HER2 null (IHC 0, no staining), HER2-ultralow (IHC 0+ with faint\u002Fincomplete staining in ≤10% of tumor cells) and HER2-low (IHC 1+, or 2+\u002FISH-negative).",[13,14,15,16],"Procedure: Upfront Breast Surgery","Radiation: Adjuvant Radiotherapy","Drug: Endocrine Therapy","Drug: Chemotherapy",{"label":18,"type":10,"description":19,"interventionNames":20},"HER2-positive ILC","HER2-positive disease, defined as IHC 3+ or IHC 2+ ISH-positive. Subgroups within this cohort will include HR-negative ILC (ER and PR both \\\u003C1%) and HR-positive (ER\\>10%) HER2-positive ILC.",[13,14,15,16],{"label":22,"type":10,"description":23,"interventionNames":24},"HR-low ILC (cross-cutting category)","ER and\u002For PR 1-10%, with neither receptor \\>10%, analyzed separately as a distinct group and also within the HER2-defined groups.",[13,14,15,16],{"label":26,"type":10,"description":27,"interventionNames":28},"Exploratory Subgroups (cross-cutting category)","Apocrine and\u002For LAR-featured ILC, and non-classic lobular variants (pleomorphic, histiocytoid and other rare histologic variants).",[13,14,15,16],[30,35,40,45],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"PROCEDURE","Upfront Breast Surgery","Upfront Conservative or Demolitive Breast Surgery",[26,18,22,9],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":10},"RADIATION","Adjuvant Radiotherapy","Adjuvant Breast or Chest Wall Radiotherapy after Breast Surgery",[26,18,22,9],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":10},"DRUG","Endocrine Therapy","Adjuvant or Neoadjuvant Endocrine Therapy",[26,18,22,9],{"type":41,"name":46,"description":47,"armGroupLabels":48,"otherNames":10},"Chemotherapy","Adjuvant or Neoadjuvant Chemotherapy",[26,18,22,9],[50],{"name":51,"affiliation":52,"role":53},"Francesco Milardi, MD","Veneto Institute of Oncology IRCCS","STUDY_CHAIR",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":10,"email":59},"Massimo Ferrucci, MD PhD","CONTACT","049 821 5500","massimoferrucci@gmail.com",{"name":61,"role":57,"phone":62,"phoneExt":10,"email":63},"Daniele Passeri, MD","+39 333 383 9397","daniele.passeri.1995@gmail.com",[65],{"facility":66,"status":67,"city":68,"state":10,"zip":10,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Veneto Institute of Oncology","RECRUITING","Padova","Italy","IT",{"type":72,"coordinates":73},"Point",[74,75],11.14261,44.38225,{"lat":75,"lon":74},[78,79,81],{"name":56,"role":57,"phone":58,"phoneExt":10,"email":59},{"name":61,"role":57,"phone":80,"phoneExt":10,"email":63},"+393333839397",{"name":82,"role":83,"phone":10,"phoneExt":10,"email":10},"Francesco Milardi","SUB_INVESTIGATOR",{"type":85,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Ferrucci Massimo","MD PhD","100639117","negativelow-hormone-receptor-and-apocrine-lobular-invasive-breast-carcinoma---a-real-world-international-cohort-study-100639117",false,"NCT07613151","Negative\u002FLow Hormone Receptor and APOcrine Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study","NAPOLI: Negative\u002FLow Hormone Receptor and APOcrine Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study","NAPOLI","Inclusion Criteria:\n\n* Female or male patients aged ≥18 years;\n* Histologically confirmed ILC, confirmed by E-cadherin loss\u002Faberrant expression and\u002For p120 cytoplasmic relocalization and\u002For CDH1 alteration;\n* HR-negative (ER \\\u003C1% and PR \\\u003C1%) or HR-low (ER and\u002For PR 1-10%) disease, as defined by ASCO\u002FCAP guidelines, is eligible regardless of HER2 status (assessed according to 2025 ASCO\u002FCAP criteria, with HER2-low and HER2-ultralow status recorded where assessable);\n* HR-positive (ER\\>10% according to the ASCO\u002FCAP guidelines) ILC is eligible only if HER2 status is positive;\n* Mixed ductal-lobular carcinomas are eligible provided that a clearly identified invasive lobular component is present and predominant (\\>50% lobular) and HR-negative\u002Flow criteria are met;\n* Stage I-III disease at diagnosis; Patients with de novo stage IV disease who underwent surgery of the primary tumor will not be included in the main study cohort but may be captured in a separate exploratory cohort for dedicated analysis;\n* Patients who underwent surgery of the primary tumor at the participating institution, either upfront or after neoadjuvant systemic treatment;\n* Diagnosis occurred between 1 January 2000 and 31 December 2025;\n* Minimum follow-up of 12 months for patients without an event, unless recurrence or death occurred earlier;\n* Local review by a dedicated breast pathologist to confirm the diagnosis and the related molecular features, with particular attention to the confirmation of apocrine morphology.\n\nExclusion Criteria:\n\n* Pure IC NST without any lobular invasive component;\n* ER or PR expression \\>10% in the invasive component, in cases with negative HER2 status;\n* In situ lobular neoplasia (lobular carcinoma in situ) without an invasive component;\n* De novo stage IV disease (such patients, if they underwent surgery of the primary tumor, will be captured in a separate exploratory cohort for a dedicated analysis)\n* Synchronous invasive BC of another dominant histology requiring systemic treatment that precludes attribution of outcomes to HR-negative\u002Flow ILC;\n* Prior invasive BC under active systemic treatment at the time of diagnosis, unless clearly documented as unrelated and not expected to confound outcomes;\n* Insufficient data or follow up","ALL","18 Years",{"count":99,"type":100},250,"ESTIMATED","OBSERVATIONAL","The NAPOLI Study is a retrospective multicenter observational study designed to characterize hormone receptor-negative\u002Flow invasive lobular carcinoma of the breast. The study will collect real-world clinicopathological, molecular, therapeutic and outcome data from patients diagnosed and treated at participating centers. The aim is to describe the clinical behavior, pathological features, receptor profile, treatments received and oncologic outcomes of this rare breast cancer subtype.",[104],"Lobular Breast Carcinoma",[106,107,108],"Breast","Cancer","Lobular Neoplasia","2026-08-03",{"date":111,"type":112},"2026-08-06","ACTUAL",{"date":114,"type":112},"2026-05-01",{"date":116,"type":100},"2027-12-31",{"name":5,"class":6},1]