Breast Cancer, Cancer
Conditions
Keywords
HER2 positive
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).
Interventions
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accrual rates | one year | Percentage of patients who receive (neo)adjuvant IV systemic therapy with trastuzumab compared to the number of participants who agree to randomization. |
| Patient compliance | One year | Percentage of participants who are randomized who accept randomization will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician engagement | One year | Percentage of medical oncologists who have agreed to participate in the trial compared to the percentage who approached patients regarding the trial. |
| Rates of events | One year | Rates of documented thrombotic events, need for anticoagulation, line infections, phlebitis, and extravasations during systemic therapy. |
Countries
Canada
Outcome results
None listed