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

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Breast Cancer, Cancer

Intervention / Treatment
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* Device: venous access PORT or PICC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Venous access PORT or PICC<br>Participants will receive a central line placement either a PORT or a PICC prior to the initiation of chemotherapy. | Device: venous access PORT or PICC<br>* Participants will receive a venous access prior to starting chemotherapy<br>|
| No Intervention: No intervention<br>Participants will only receive a central line if required once chemotherapy has been initiated. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Rates of thrombotic events | 2. Rates of documented thrombotic events need for anticoagulation, line infections, phlebitis, and extravasations during chemotherapy. | One year | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HER2 negative