Randomized Trial Standard of Care Vascular Access Strategies for (Neo)Adjuvant Trastuzumab-based Breast Cancer Treatment.
NCT ID: NCT02632435
Last Updated: 2019-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2016-04-30
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Peripherally inserted central catheter
PICC line will be inserted for the delivery and duration of chemotherapy.
PICC
Participants will be randomized to a PICC for vascular access during chemotherapy.
portacath
PORT will be inserted for the delivery and duration of chemotherapy and trastuzumab.
PORT
Participants will be randomized to a PORT for vascular access during chemotherapy
Interventions
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PICC
Participants will be randomized to a PICC for vascular access during chemotherapy.
PORT
Participants will be randomized to a PORT for vascular access during chemotherapy
Eligibility Criteria
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Inclusion Criteria
* 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.
* ≥19 years of age
* Able to provide verbal consent
Exclusion Criteria
19 Years
FEMALE
No
Sponsors
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Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Mark Clemons, MD
Role: PRINCIPAL_INVESTIGATOR
The Ottawa Hospital
Locations
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The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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15-089
Identifier Type: -
Identifier Source: org_study_id
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