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

Breast Cancer Clinical Trial

— OTT 15-07  

Official 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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02688998
• Other study ID #: 20160006-01H
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: February 2019

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer

Intervention

Device:
• venous access PORT or PICC
Participants will receive a venous access prior to starting 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 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.	One year
Primary	Patient compliance	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	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 thrombotic events	2. Rates of documented thrombotic events need for anticoagulation, line infections, phlebitis, and extravasations during chemotherapy.	One year
Secondary	Number of attempts at cannulation	3. 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)	One year