NCT02632435

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

September 6, 2019

Status Verified

August 1, 2019

Enrollment Period

3.1 years

First QC Date

December 8, 2015

Last Update Submit

September 3, 2019

Conditions

Breast CancerCancer

Keywords

HER2 positive

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Physician engagement

    One year

  • Rates of events

    One year

Study Arms (2)

Peripherally inserted central catheter

OTHER

PICC line will be inserted for the delivery and duration of chemotherapy.

Device: PICC

portacath

OTHER

PORT will be inserted for the delivery and duration of chemotherapy and trastuzumab.

Device: PORT

Interventions

PICCDEVICE

Participants will be randomized to a PICC for vascular access during chemotherapy.

Peripherally inserted central catheter
PORTDEVICE

Participants will be randomized to a PORT for vascular access during chemotherapy

portacath

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindication to central line placement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (1)

  • Clemons M, Stober C, Kehoe A, Bedard D, MacDonald F, Brunet MC, Saunders D, Vandermeer L, Mazzarello S, Awan A, Basulaiman B, Robinson A, Mallick R, Hutton B, Fergusson D. A randomized trial comparing vascular access strategies for patients receiving chemotherapy with trastuzumab for early-stage breast cancer. Support Care Cancer. 2020 Oct;28(10):4891-4899. doi: 10.1007/s00520-020-05326-y. Epub 2020 Jan 30.

    PMID: 32002617DERIVED

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mark Clemons, MD

    The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2015

First Posted

December 16, 2015

Study Start

April 1, 2016

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

September 6, 2019

Record last verified: 2019-08

Locations

CA(1)