[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634654":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":57,"studyPopulation":58,"armGroups":59,"interventions":55,"overallOfficials":55,"centralContacts":55,"locations":66,"responsibleParty":94,"collaborators":96,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":55,"enrollmentInfo":111,"targetDuration":55,"studyType":114,"phases":55,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":69,"whyStopped":55,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Société Algérienne de Formation et Recherche en Oncologie","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":50},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"Treatment Regimen Utilization","Percentage (%) of patients receiving each pertuzumab biosimilar-containing treatment regimen.","Up to 36 months",{"measure":14,"description":15,"timeFrame":12},"Line of Therapy","Percentage (%) of patients receiving pertuzumab biosimilar as neoadjuvant therapy or first-line treatment in metastatic setting.",{"measure":17,"description":18,"timeFrame":12},"Treatment Duration","Median duration of treatment (in months) with pertuzumab biosimilar.",{"measure":20,"description":21,"timeFrame":12},"Prescribing Context","Percentage (%) of prescriptions initiated in neoadjuvant versus metastatic setting.",{"measure":23,"description":24,"timeFrame":12},"Methods of Response Assessment","Percentage (%) of patients assessed using clinical, radiological, and\u002For pathological methods.",[26,30,34,38,41,44,47],{"measure":27,"description":28,"timeFrame":29},"Pathological Complete Response (pCR) Rate (Neoadjuvant Cohort)","Proportion of patients achieving pathological complete response (pCR) based on local histopathological assessment.","Up to 12 months",{"measure":31,"description":32,"timeFrame":33},"Disease-Free Survival (DFS) (Neoadjuvant Cohort)","Time from surgery to disease recurrence or death from any cause.","Up to 24 months",{"measure":35,"description":36,"timeFrame":37},"Progression-Free Survival Rate at 24 Months (PFSR) (Metastatic Cohort)","Proportion of patients alive without disease progression at 24 months.","24 months",{"measure":39,"description":40,"timeFrame":33},"Progression-Free Survival (PFS) (Metastatic Cohort)","Time from treatment initiation to disease progression or death from any cause.",{"measure":42,"description":43,"timeFrame":33},"Treatment Response (Both Cohorts)","Clinical, radiological, and\u002For pathological response assessed according to routine clinical practice.",{"measure":45,"description":46,"timeFrame":33},"Overall Survival (OS) (Both Cohorts)","Time from treatment initiation to death from any cause.",{"measure":48,"description":49,"timeFrame":33},"Incidence and Severity of Adverse Events","Incidence (%) and severity of adverse events (AEs), graded according to Common Terminology Criteria for Adverse Events (CTCAE).",[51],{"measure":52,"description":53,"timeFrame":33},"Correlation Between Clinical and Biological Factors and Treatment Response","Assessment of correlation between treatment response (based on clinical, radiological, or pathological evaluation) and clinical and biological factors including age, tumor grade, hormonal receptor status, Ki-67, menopausal status, comorbidities, and treatment characteristics, using regression analysis. Results will be reported as odds ratios (OR) with 95% confidence intervals (CI).",{"allocation":55,"interventionModel":55,"interventionModelDescription":55,"primaryPurpose":55,"observationalModel":56,"timePerspective":6,"maskingInfo":55},null,"COHORT","This is a non-interventional, prospective, multicenter, bicohort observational study conducted in a real-world setting. It aims to describe the clinical and therapeutic characteristics of patients treated with a pertuzumab biosimilar and to evaluate outcomes in both neoadjuvant and metastatic settings. Approximately 1,000 patients will be included, with 500 patients per cohort. Cohort 1 includes patients receiving a pertuzumab biosimilar in the neoadjuvant treatment of HER2-positive breast cancer, while Cohort 2 includes patients treated in the first-line metastatic setting for HER2-positive metastatic breast cancer.","Adult women with HER2-positive breast cancer receiving a pertuzumab biosimilar in the neoadjuvant setting or as first-line treatment in the metastatic setting.",[60,63],{"label":61,"type":55,"description":62,"interventionNames":55},"Cohort 1","Patients treated with a pertuzumab biosimilar in the neoadjuvant setting for HER2-positive breast cancer.",{"label":64,"type":55,"description":65,"interventionNames":55},"Cohort 2","Patients treated with a pertuzumab biosimilar as first-line therapy in the metastatic setting for HER2-positive metastatic breast cancer.",[67,85],{"facility":68,"status":69,"city":70,"state":55,"zip":55,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"CAC BLIDA, Algiers, Algeria 16000","RECRUITING","Algiers","Algeria","DZ",{"type":74,"coordinates":75},"Point",[76,77],3.08746,36.73225,{"lat":77,"lon":76},[80],{"name":81,"role":82,"phone":83,"phoneExt":55,"email":84},"BOUNEDJAR Adda, Professor","CONTACT","+213 25 20 90 72","contact@esclinicalresearch.com",{"facility":86,"status":69,"city":70,"state":55,"zip":55,"country":71,"countryCode":72,"cosmosGeoPoint":87,"geoPoint":89,"contacts":90},"CHU Béni Messous, Algiers, Algeria 16000",{"type":74,"coordinates":88},[76,77],{"lat":77,"lon":76},[91],{"name":92,"role":82,"phone":93,"phoneExt":55,"email":84},"Oukkal Mohammed, Professor","+213 219 311 90",{"type":95,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR",[97,100],{"name":98,"class":99},"ES Clinical Research","UNKNOWN",{"name":101,"class":99},"AlgenPharm","100634654","real-world-bicohort-observational-study-of-a-pertuzumab-biosimilar-in-the-treatment-of-breast-cancer-in-the-neoadjuvant-setting-and-in-first-line-metastatic-disease-100634654",false,"NCT07542496","Real-world Bicohort Observational Study of a Pertuzumab Biosimilar in the Treatment of Breast Cancer: in the Neoadjuvant Setting and in First-line Metastatic Disease","PERTUREAL","Inclusion Criteria:\n\n* Age ≥ 19 years at the time of inclusion;\n* Histologically confirmed diagnosis of HER2-positive invasive breast cancer (IHC 3+ score or HER2 amplification by FISH\u002FCISH\u002FSISH);\n* Decision to initiate treatment with a pertuzumab biosimilar in the neoadjuvant setting (neoadjuvant cohort) or as first-line therapy in the metastatic setting (metastatic cohort), in accordance with local indications;\n* Treatment prescribed as part of routine clinical care (outside of a clinical trial);\n* Patient informed and having provided written informed consent.\n\nExclusion Criteria:\n\n* Treatment with pertuzumab in a therapeutic setting other than neoadjuvant or first-line metastatic (e.g., adjuvant, late recurrence beyond first-line, maintenance therapy alone, etc.);\n* Treatment administered as part of an interventional clinical trial;\n* History of severe allergy or known contraindication to pertuzumab;\n* Medical records unavailable or inability to ensure at least 6 months of minimal follow-up.","FEMALE","19 Years",{"count":112,"type":113},1000,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to describe the real-world utilization patterns of a pertuzumab biosimilar and to evaluate its clinical outcomes in patients with breast cancer in both neoadjuvant and metastatic settings. It also aims to assess pathological complete response (pCR), disease-free survival (DFS) in the neoadjuvant cohort, progression-free survival (PFS) in the metastatic cohort, overall survival (OS), treatment response, and safety and tolerability (adverse events according to CTCAE) across both cohorts.",[117,118],"Breast Cancer","Her 2 Positive Breast Cancer",[120,121,71,122,123,117,124,125,126,127,128,129,130,131,132],"Algerian Study","Real-world data","Biosimilar","Pertuzumab","Cancer","Breast cancer in Algerian patients","HER2-Positive Breast Cancer","Neoadjuvant Therapy","Anti-HER2 Therapy","Cohort Study","Non-Interventional Study","HER2-Targeted Therapy","Observational Study","2026-04-14",{"date":135,"type":136},"2026-04-21","ACTUAL",{"date":138,"type":136},"2026-01-15",{"date":140,"type":113},"2027-01-15",{"name":5,"class":6},2]