[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497159":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":83,"collaborators":33,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":33,"enrollmentInfo":95,"targetDuration":33,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":51,"whyStopped":33,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Ottawa Hospital Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Receive G-CSF","ACTIVE_COMPARATOR","Receive G-CSF injections (either filgrastim or pegfilgrastim) after each cycle of paclitaxel chemotherapy.",[13],"Drug: Granulocyte Colony-Stimulating Factor (G-CSF)",{"label":15,"type":16,"description":17,"interventionNames":18},"Omission of G-CSF","EXPERIMENTAL","Omission of G-CSF injections after each cycle of paclitaxel chemotherapy.",[19],"Drug: Omission of Granulocyte Colony-Stimulating Factor (G-CSF)",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Granulocyte Colony-Stimulating Factor (G-CSF)","Participants will receive G-CSF injection (either filgrastim or pegfilgrastim) after each paclitaxel cycle of DD-AC\u002FT chemotherapy.",[9],[27,28],"Filgrastim","Pegfilgrastim",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Omission of Granulocyte Colony-Stimulating Factor (G-CSF)","Participants will omit the use of G-CSF (either filgrastim or pegfilgrastim) after each paclitaxel cycle of DD-AC\u002FT chemotherapy",[15],null,[35],{"name":36,"affiliation":5,"role":37},"Xinni Song, MD","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":33,"email":43},"Lisa Vandermeer, MSc","CONTACT","613-737-7700","lvandermeer@ohri.ca",{"name":45,"role":41,"phone":42,"phoneExt":46,"email":47},"Carol Stober","77226","cstober@toh.ca",[49,63,72],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":33},"Kingston Health Sciences Centre","RECRUITING","Kingston","Ontario","K7L 2V7","Canada","CA",{"type":58,"coordinates":59},"Point",[60,61],-76.48098,44.22976,{"lat":61,"lon":60},{"facility":64,"status":51,"city":65,"state":53,"zip":66,"country":55,"countryCode":56,"cosmosGeoPoint":67,"geoPoint":71,"contacts":33},"Lakeridge Health","Oshawa","L1G 2B9",{"type":58,"coordinates":68},[69,70],-78.84957,43.90012,{"lat":70,"lon":69},{"facility":73,"status":51,"city":74,"state":53,"zip":75,"country":55,"countryCode":56,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"The Ottawa Hospital Cancer Centre","Ottawa","K1H 8L6",{"type":58,"coordinates":77},[78,79],-75.69812,45.41117,{"lat":79,"lon":78},[82],{"name":40,"role":41,"phone":42,"phoneExt":33,"email":43},{"type":84,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100497159","phase-4-evaluating-omission-of-granulocyte-colony-stimulating-factors-in-breast-cancer-patients-receiving-paclitaxel-portion-of-dose-dense-adriamycin-cyclophosphamide-and-paclitaxel-chemotherapy-100497159",false,"NCT05753618","Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy","A Randomized Pragmatic Trial Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy (REaCT-OGF)","REaCT-OGF","Inclusion Criteria:\n\n* Patients with early-stage or locally-advanced breast cancer receiving neoadjuvant or adjuvant DD-AC\u002FT chemotherapy requiring primary febrile neutropenia prophylaxis with G-CSF\n* Able to provide verbal consent\n* Able to complete questionnaires in English or French\n\nExclusion Criteria:\n\n* No access to pegfilgrastim or filgrastim prior to randomization\n* Metastatic cancer\n* Known hypersensitivity to filgrastim or pegfilgrastim or one of its components\n* Patients received prior cytotoxic chemotherapy within the last 5 years\n* Patients with uncontrolled inter-current illness that would limit compliance with study requirements or other significant diseases or disorders that, in the investigator's opinion, would exclude the subject from participating in the study","ALL","18 Years",{"count":96,"type":97},242,"ESTIMATED","INTERVENTIONAL",[100],"PHASE4","The goal of this randomized, pragmatic clinical trial is to evaluate the omission of granulocyte colony-stimulating factors (G-CSF) in breast cancer patients receiving paclitaxel portion of dose-dense adriamycin-cyclophosphamide and paclitaxel (DD-AC\u002FT) chemotherapy. Participants will be randomized to either take G-CSF while on the paclitaxel portion of DD-AC\u002FT chemotherapy or to omit G-CSF while on the paclitaxel portion of DD-AC\u002FT chemotherapy.",[103],"Early-stage Breast Cancer",[27,28,105,106],"Bone pain","Paclitaxel","2026-02-05",{"date":109,"type":110},"2026-02-09","ACTUAL",{"date":112,"type":110},"2023-04-17",{"date":114,"type":97},"2026-10",{"name":5,"class":6},3]