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Randomized Trial Standard of Care Vascular Access Strategies for (Neo)Adjuvant Trastuzumab-based Breast Cancer Treatment. (OTT 15-06)

Primary Purpose

Breast Cancer, Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PICC
PORT
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring HER2 positive

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The Ottawa Hospital Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Peripherally inserted central catheter

portacath

Arm Description

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

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

Outcomes

Primary Outcome Measures

Accrual rates
Percentage of patients who receive (neo)adjuvant IV systemic therapy with trastuzumab compared to the number of participants who agree to randomization.
Patient compliance
Percentage of participants who are randomized who accept randomization will be calculated.

Secondary Outcome Measures

Physician engagement
Percentage of medical oncologists who have agreed to participate in the trial compared to the percentage who approached patients regarding the trial.
Rates of events
Rates of documented thrombotic events, need for anticoagulation, line infections, phlebitis, and extravasations during systemic therapy.

Full Information

First Posted
December 8, 2015
Last Updated
September 3, 2019
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02632435
Brief Title
Randomized Trial Standard of Care Vascular Access Strategies for (Neo)Adjuvant Trastuzumab-based Breast Cancer Treatment.
Acronym
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).
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cancer
Keywords
HER2 positive

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peripherally inserted central catheter
Arm Type
Other
Arm Description
PICC line will be inserted for the delivery and duration of chemotherapy.
Arm Title
portacath
Arm Type
Other
Arm Description
PORT will be inserted for the delivery and duration of chemotherapy and trastuzumab.
Intervention Type
Device
Intervention Name(s)
PICC
Intervention Description
Participants will be randomized to a PICC for vascular access during chemotherapy.
Intervention Type
Device
Intervention Name(s)
PORT
Intervention Description
Participants will be randomized to a PORT for vascular access during chemotherapy
Primary Outcome Measure Information:
Title
Accrual rates
Description
Percentage of patients who receive (neo)adjuvant IV systemic therapy with trastuzumab compared to the number of participants who agree to randomization.
Time Frame
one year
Title
Patient compliance
Description
Percentage of participants who are randomized who accept randomization will be calculated.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Physician engagement
Description
Percentage of medical oncologists who have agreed to participate in the trial compared to the percentage who approached patients regarding the trial.
Time Frame
One year
Title
Rates of events
Description
Rates of documented thrombotic events, need for anticoagulation, line infections, phlebitis, and extravasations during systemic therapy.
Time Frame
One year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Clemons, MD
Organizational Affiliation
The Ottawa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
32002617
Citation
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.
Results Reference
derived

Learn more about this trial

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

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