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Completed

NCT Number: NCT02688998

REaCT-vascular Access Her2 Negative Vascular Access Strategies for (Neo) Adjuvant Breast Cancer Treatment Without Trastuzumab

In the REaCT-Vascular Access Her2 negative study, 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.

Determining the optimal vascular access strategy remains an important medical issue for patients, nurses, physicians and society. A novel method to allow comparison of established standards of care is needed as part of an increasing internationally mandated incentive to perform more pragmatic clinic trials.

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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 either FEC-D, AC-D, dose-dense AC-T, TAC, or TC chemotherapy, in the adjuvant or neoadjuvant setting.
  • ≥19 years of age
  • Able to provide verbal consent

Exclusion criteria

  • Contraindication to central line placement.

Treatment and study plan

venous access PORT or PICC

Device

Participants will receive a venous access prior to starting chemotherapy

Primary outcomes

  1. Accrual rates

    Time frame: One year

    Percentage of patients who receive (neo)adjuvant IV systemic therapy for Her 2 negative breast cancer compared to the number of participants who agree to randomization. The total number of new patients receiving (neo) adjuvant IV systemic cytotoxic therapy will be provided by the local chemotherapy pharmacy and Oncology Patient Information System records.

  2. Patient compliance

    Time frame: One year

    Percentage of participants who are randomized who accept randomization, and percentage of patients who cross-over to receive a central line while on study will be calculated using the chemotherapy treatment documentation in the designated hospital electronic patient record program

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 thrombotic events

    Time frame: One year

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

  3. Number of attempts at cannulation

    Time frame: One year

    • For those patients randomised to peripheral access information on the number of attempts at cannulation will be collected and site of cannulation. (ipsilateral to surgery vs contralateral to surgery)

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

Simple, Prospective and Randomized Trial to Obtain Answers to Questions of Standard of Care: Vascular Access Strategies for (Neo) Adjuvant Breast Cancer Treatment Without Trastuzumab: A Study From the REthinking Clinical Trials Program (REaCT-vascular Access Her2 Negative).

Acronym: OTT 15-07

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 23, 2016
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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