Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-30 @ 5:25 AM
Study NCT ID:
NCT04781959
Status:
COMPLETED
Last Update Posted:
2025-03-21
First Post:
2021-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Multicenter Pragmatic Trial Comparing Bone Pain From a Single Dose of Pegfilgrastim to 5 Doses of Daily Filgrastim in Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-11-25', 'releaseDate': '2025-11-14'}], 'estimatedResultsFirstSubmitDate': '2025-11-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'C455861', 'term': 'pegfilgrastim'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 233}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2021-03-01', 'studyFirstSubmitQcDate': '2021-03-01', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone pain', 'timeFrame': '5 days after first G-CSF injection', 'description': "Bone pain over the first 5 days after the administration of G-CSF. The total measure of bone pain over the five days will be summarized by the area under the curve (AUC) based on a patient's daily pain score, starting after the first dose of G-CSF injection."}], 'secondaryOutcomes': [{'measure': 'Incidence of Febrile Neutropenia', 'timeFrame': '2.5 years after study initiation', 'description': 'Number of times participants have Febrile neutropenia during chemotherapy treatment'}, {'measure': 'Incidence of treatment-related hospitalizations', 'timeFrame': '2.5 years after study initiation', 'description': 'Number of times participants have a treatment-related hospitalization'}, {'measure': 'Incidence of chemotherapy alteration', 'timeFrame': '2.5 years after study initiation', 'description': 'Number of times participants have a chemotherapy alteration including: dose delay, reduction and/or discontinuation'}, {'measure': 'Incidence of chemotherapy-related mortality', 'timeFrame': '2.5 years after study initiation', 'description': 'Number of times there is a chemotherapy-related mortality'}, {'measure': 'Rate of G-CSF compliance as prescribed', 'timeFrame': '2.5 years after study initiation', 'description': 'Number of times there is a G-CSF compliance'}, {'measure': 'Differences in healthcare resource utilization', 'timeFrame': '2.5 years after study initiation', 'description': 'Differences in healthcare resource utilization: number of emergency room visits, number of planned/unplanned provider clinic visits (including stretcher bay), patient-reported phone calls or email to patient support line or provider, and additional medication use or management strategies related to G-CSF side effects or efficacy'}, {'measure': 'HR-QoL', 'timeFrame': '2.5 years after study initiation', 'description': 'HR-QoL based on EQ-5D-5L'}, {'measure': 'Cost-effectiveness', 'timeFrame': '2.5 years after study initiation', 'description': 'Cost differences associated with prescribing Filgrastim and Pegfilgrastim'}, {'measure': 'Patient G-CSF preference', 'timeFrame': '2.5 years after study initiation', 'description': 'To survey patient preference in selection of G-CSF treatment before and after undergoing chemotherapy and G-CSF treatment'}, {'measure': 'Study feasibility', 'timeFrame': '1 year after study initiation', 'description': 'Interim analysis/feasibility. After the first year of study initiation, if study recruitment is less than 30% at one year (70 patients), or if there are unanticipated safety issues, a review of study conduct will be performed to consider stopping the study unless there are unexpected or exceptional reasons, or in the case of low recruitment, there is a plan to boost recruitment efforts'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Filgrastim', 'Pegfilgrastim'], 'conditions': ['Early-stage Breast Cancer']}, 'descriptionModule': {'briefSummary': 'REaCT-5G will compare bone pain from a single dose of Pegfilgrastim to 5 doses of daily filgrastim in breast cancer patients receiving neoadjuvant/adjuvant chemotherapy.', 'detailedDescription': 'The use of granulocyte colony-stimulating factors (G-CSF) significantly reduces febrile neutropenia (FN) risk and has helped maintain dose intensity and dose density when treating breast cancer with chemotherapy. This is crucial as survival outcomes are significantly impaired if dose intensity are reduced. National and international guidelines recommend the use of G-CSF as primary prophylaxis with most commonly used breast cancer chemotherapy regimens. Filgrastim (FIL) as a G-CSF that has been in use since the early 90s. Pegfilgrastim (PEG) is a long-acting, pegylated version of FIL that requires only one injection per chemotherapy cycle instead of daily FIL injections for 5 to 10 days per cycle. PEG and FIL both come at the potential cost of bone pain, the most common side effect. G-CSF related bone pain is often severe, leading to refusal or cancellation of G-CSF and early discontinuation of chemotherapy. We propose to perform a pragmatic, multicenter, open-label, randomized clinical trial to compare bone pain experienced by patients receiving either PEG or 5-day-FIL with neoadjuvant or adjuvant chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with early-stage or locally-advanced breast cancer receiving neoadjuvant or adjuvant 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'}, 'identificationModule': {'nctId': 'NCT04781959', 'briefTitle': 'A Randomized, Multicenter Pragmatic Trial Comparing Bone Pain From a Single Dose of Pegfilgrastim to 5 Doses of Daily Filgrastim in Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'A Randomized, Multicenter Pragmatic Trial Comparing Bone Pain From a Single Dose of Pegfilgrastim to 5 Doses of Daily Filgrastim in Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy (REaCT-5G)', 'orgStudyIdInfo': {'id': 'REaCT-5G'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '5 Days of Filgrastim', 'description': 'Receive filgrastim subcutaneous injection once daily for five consecutive days starting 24-72 hours after chemotherapy.', 'interventionNames': ['Drug: Filgrastim']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pegfilgrastim', 'description': 'Receive pegfilgrastim as a single dose subcutaneous injection 24-72 hours after chemotherapy', 'interventionNames': ['Drug: Pegfilgrastim']}], 'interventions': [{'name': 'Filgrastim', 'type': 'DRUG', 'otherNames': ['Neupogen'], 'description': 'Receive filgrastim subcutaneous injection once daily for five consecutive days starting 24-72 hours after chemotherapy', 'armGroupLabels': ['5 Days of Filgrastim']}, {'name': 'Pegfilgrastim', 'type': 'DRUG', 'otherNames': ['Neulasta'], 'description': 'Receive pegfilgrastim as a single dose subcutaneous injection 24-72 hours after chemotherapy', 'armGroupLabels': ['Pegfilgrastim']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital Research Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'P7B 6V4', 'city': 'Thunder Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Thunder Bay Regional Health Sciences Centre', 'geoPoint': {'lat': 48.38202, 'lon': -89.25018}}], 'overallOfficials': [{'name': 'Terry Ng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Hospital Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-14', 'type': 'RELEASE'}, {'date': '2025-11-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ottawa Hospital Research Institute'}}}}