Randomized Trial Standard of Care Vascular Access Strategies for (Neo)Adjuvant Trastuzumab-based Breast Cancer Treatment.

Study Overview
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Brief Summary
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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).

Official Title
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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).

Conditions
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Breast Cancer, Cancer

Intervention / Treatment
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* Device: PICC
* Device: PORT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Peripherally inserted central catheter<br>PICC line will be inserted for the delivery and duration of chemotherapy. | Device: PICC<br>* Participants will be randomized to a PICC for vascular access during chemotherapy.<br>|
| Other: portacath<br>PORT will be inserted for the delivery and duration of chemotherapy and trastuzumab. | Device: PORT<br>* Participants will be randomized to a PORT for vascular access during chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accrual rates | Percentage of patients who receive (neo)adjuvant IV systemic therapy with trastuzumab compared to the number of participants who agree to randomization. | one year | 
| Patient compliance | Percentage of participants who are randomized who accept randomization will be calculated. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician engagement | Percentage of medical oncologists who have agreed to participate in the trial compared to the percentage who approached patients regarding the trial. | One year | 
| Rates of events | Rates of documented thrombotic events, need for anticoagulation, line infections, phlebitis, and extravasations during systemic therapy. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HER2 positive