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

Breast Cancer Clinical Trial

— OTT 15-06  

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632435
• Other study ID #: 15-089
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: May 2019

Study information

• Verified date: August 2019
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer

Intervention

Device:
• 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

Locations

Country	Name	City	State
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patient compliance	Percentage of participants who are randomized who accept randomization will be calculated.	One year
Secondary	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
Secondary	Rates of events	Rates of documented thrombotic events, need for anticoagulation, line infections, phlebitis, and extravasations during systemic therapy.	One year