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Completed

NCT Number: NCT02632435

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

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).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PICC

Device

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

PORT

Device

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

Primary outcomes

  1. Accrual rates

    Time frame: one year

    Percentage of patients who receive (neo)adjuvant IV systemic therapy with trastuzumab compared to the number of participants who agree to randomization.

  2. Patient compliance

    Time frame: One year

    Percentage of participants who are randomized who accept randomization will be calculated.

Secondary outcomes

  1. Physician engagement

    Time frame: One year

    Percentage of medical oncologists who have agreed to participate in the trial compared to the percentage who approached patients regarding the trial.

  2. Rates of events

    Time frame: One year

    Rates of documented thrombotic events, need for anticoagulation, line infections, phlebitis, and extravasations during systemic therapy.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study 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).

Acronym: OTT 15-06

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 16, 2015
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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