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).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Patient compliance
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed primary breast cancer
- •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
- •Contraindication to central line placement.
Arms & Interventions
Peripherally inserted central catheter
PICC line will be inserted for the delivery and duration of chemotherapy.
Intervention: PICC (Device)
portacath
PORT will be inserted for the delivery and duration of chemotherapy and trastuzumab.
Intervention: PORT (Device)
Outcomes
Primary Outcomes
Patient compliance
Time Frame: One year
Percentage of participants who are randomized who accept randomization will be calculated.
Accrual rates
Time Frame: one year
Percentage of patients who receive (neo)adjuvant IV systemic therapy with trastuzumab compared to the number of participants who agree to randomization.
Secondary Outcomes
- Rates of events(One year)
- Physician engagement(One year)