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

Not Applicable

Completed

• Conditions: Cancer; Breast Cancer
• Interventions: Device: PICC; Device: PORT

• Registration Number: NCT02632435
• Lead Sponsor: Ottawa Hospital Research Institute

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-08
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-16
• Study Start: 2016-04
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2019-08
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peripherally inserted central catheter	PICC	PICC line will be inserted for the delivery and duration of chemotherapy.
portacath	PORT	PORT will be inserted for the delivery and duration of chemotherapy and trastuzumab.

Primary Outcome Measures

Name	Time	Method
Patient compliance	One year	Percentage of participants who are randomized who accept randomization will be calculated.
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.

Secondary Outcome Measures

Name	Time	Method
Rates of events	One year	Rates of documented thrombotic events, need for anticoagulation, line infections, phlebitis, and extravasations during systemic therapy.
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.

Trial Locations

Locations (1)

The Ottawa Hospital Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada