Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-04-12 @ 12:34 AM
Study NCT ID:
NCT02632435
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2015-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial Standard of Care Vascular Access Strategies for (Neo)Adjuvant Trastuzumab-based Breast Cancer Treatment.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-08-11', 'releaseDate': '2022-09-29'}], 'estimatedResultsFirstSubmitDate': '2022-09-29'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-03', 'studyFirstSubmitDate': '2015-12-08', 'studyFirstSubmitQcDate': '2015-12-11', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accrual rates', 'timeFrame': 'one year', 'description': 'Percentage of patients who receive (neo)adjuvant IV systemic therapy with trastuzumab compared to the number of participants who agree to randomization.'}, {'measure': 'Patient compliance', 'timeFrame': 'One year', 'description': 'Percentage of participants who are randomized who accept randomization will be calculated.'}], 'secondaryOutcomes': [{'measure': 'Physician engagement', 'timeFrame': 'One year', 'description': 'Percentage of medical oncologists who have agreed to participate in the trial compared to the percentage who approached patients regarding the trial.'}, {'measure': 'Rates of events', 'timeFrame': 'One year', 'description': 'Rates of documented thrombotic events, need for anticoagulation, line infections, phlebitis, and extravasations during systemic therapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HER2 positive'], 'conditions': ['Breast Cancer', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '32002617', 'type': 'DERIVED', 'citation': 'Clemons M, Stober C, Kehoe A, Bedard D, MacDonald F, Brunet MC, Saunders D, Vandermeer L, Mazzarello S, Awan A, Basulaiman B, Robinson A, Mallick R, Hutton B, Fergusson D. A randomized trial comparing vascular access strategies for patients receiving chemotherapy with trastuzumab for early-stage breast cancer. Support Care Cancer. 2020 Oct;28(10):4891-4899. doi: 10.1007/s00520-020-05326-y. Epub 2020 Jan 30.'}]}, 'descriptionModule': {'briefSummary': 'In the REaCT-Vascular Access Trastuzumab study (REaCT-VA), the investigator will use a novel method to allow comparisons of established standard of care vascular access strategies using the "integrated consent model" as part of a pragmatic clinical trial. The investigator wishes to address a non-pharmacologic issue regarding standard of care vascular access devices. Peripherally inserted central catheters (PICC lines) versus subcutaneously implanted devices (PORTs).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Histologically confirmed primary breast cancer\n* Planned to start trastuzumab based neo/adjuvant therapy: FEC-DH or AC-DH, or; dose-dense AC-TH, or docetaxel/cyclophosphamide/trastuzumab or docetaxel/carboplatin/trastuzumab, or weekly paclitaxel with trastuzumab.\n* ≥19 years of age\n* Able to provide verbal consent\n\nExclusion Criteria\n\n• Contraindication to central line placement.'}, 'identificationModule': {'nctId': 'NCT02632435', 'acronym': 'OTT 15-06', 'briefTitle': 'Randomized Trial Standard of Care Vascular Access Strategies for (Neo)Adjuvant Trastuzumab-based Breast Cancer Treatment.', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'A Pragmatic Randomized Trial Standard of Care Vascular Access Strategies for (Neo)Adjuvant Trastuzumab-based Breast Cancer Treatment OTT 15-06 A Study From the REthinking Clinical Trials Program (REaCT-vascular Access Trastuzumab Study).', 'orgStudyIdInfo': {'id': '15-089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Peripherally inserted central catheter', 'description': 'PICC line will be inserted for the delivery and duration of chemotherapy.', 'interventionNames': ['Device: PICC']}, {'type': 'OTHER', 'label': 'portacath', 'description': 'PORT will be inserted for the delivery and duration of chemotherapy and trastuzumab.', 'interventionNames': ['Device: PORT']}], 'interventions': [{'name': 'PICC', 'type': 'DEVICE', 'description': 'Participants will be randomized to a PICC for vascular access during chemotherapy.', 'armGroupLabels': ['Peripherally inserted central catheter']}, {'name': 'PORT', 'type': 'DEVICE', 'description': 'Participants will be randomized to a PORT for vascular access during chemotherapy', 'armGroupLabels': ['portacath']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital Cancer Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Mark Clemons, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Ottawa Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-09-29', 'type': 'RELEASE'}, {'date': '2023-08-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ottawa Hospital Research Institute'}}}}